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Medical device recalls (FDA)
Medical device recalls from the FDA Enforcement Report and FDA announcements - pumps, monitors, test kits, implants and more - newest first. Updated automatically every 30 minutes.
3165recalls in the last 12 months
327Class I (most serious)
Sep 25, 2026most recent
CLASS I may cause serious illness or deathCLASS II temporary/reversible harmCLASS III unlikely to cause harm
FORWARD Gunshot Wound Kit
INTEGRATED MEDCRAFT LLC
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade o…
HexaVue Focus Integration System
Steris Corporation
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a docum…
RAPICIDE PA Part A High-Level Disinfectant
Steris Corporation
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from …
RAPICIDE PA Part A High-Level Disinfectant
Steris Corporation
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from …
RAPICIDE PA Part A High-Level Disinfectant
Steris Corporation
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from …
TS Misc. Instruments Tray
Howmedica Osteonics Corp.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m…
Triathlon Hinge Femoral Prep Tray.
Howmedica Osteonics Corp.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m…
TS Femoral Prep Tray
Howmedica Osteonics Corp.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m…
TS Universal Baseplate Finishing Tray
Howmedica Osteonics Corp.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m…
Williams Cystoscopic Injection Needles
Cook Incorporated
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential ev…
NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Pro
Baxter Healthcare Corporation
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quic…
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Medline Industries, LP
Discrepancy in the shelf-life of a component
NaviFlex LW Pusher
Boston Scientific Corporation
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
REF: P65 ST862 CoLag SCREW
In2bones USA, LLC
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture
Ethicon, LLC
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior t…
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station
Nihon Kohden America LLC
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds…
Vinyl Instrument Guards
Healthmark Industries Co., Inc.
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
IntelePACS
INTELERAD MEDICAL SYSTEMS INCORPORATED
Following a Chromium-based web-browser, report and displayed images may not match.
LeadCare II Blood Lead Test Kit.
Magellan Diagnostics, Inc.
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2…
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathi
Draeger, Inc.
Potential cracks in the hose, which could lead to leakage or the hose falling off.
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis
W L Gore & Associates, Inc.
The potential for the devices to be mislabeled with the incorrect length.
HemoslL AcuStar HIT-lgG
Instrumentation Laboratory
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
HemoslL AcuStar HIT-lgG
Instrumentation Laboratory
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Medline surgical convenience kits labeled as: 1) SPINAL CDS
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: OPEN HEART
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) EAR
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
1) Product Name AUD OPEN HEART PACK
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK
Medline Industries, LP
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin…
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE
Beckman Coulter Inc.
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us…
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE
Beckman Coulter Inc.
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use …
Battle Bandage
Safeguard US Operating LLC
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s…
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911
Medline Industries, LP
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result…
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneView Series. Operator's Manuals: T5 / T8
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-6
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM
Mindray DS USA, Inc.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
VERIFY Biological Steam Test Pack
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
VERIFY Biological Steam Test Pack
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
VERIFY Dual Species Self-Contained Biological Indicator
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
VERIFY Dual Species Self-Contained Biological Indicator
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
VERIFY Biological/Integrator Challenge Pack
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
VERIFY Biological/Integrator Challenge Pack
Steris Corporation
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Evolution upgrade 1.5T amd Evolution upgrade 3.0T
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
Upgrade to MR 7700
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
Upgrade dStream
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
SmartPath to MR 7700
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
SmartPath to dStream for 1.5T
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
MR 7700
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
MR 5300
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
Ingenia Elition S and Ingenia Elition X.
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced …
Ingenia Ambition S and Ingenia Ambition X.
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced…
Ingenia 3.0T and 3.0T CX
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced…
Ingenia 1.5T
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced…
Ingenia Blue Seal SE and Blue Seal XE
Philips North America
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced…
Intellijoint Navigation System: Workstation G2 Configured
Intellijoint Surgical, Inc.
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an…
TufTex¿ Over-the-Wire Embolectomy Catheter
LeMaitre Vascular, Inc.
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Olympus Tripp-Lite P580-025 25ft DisplayPort Cable
Olympus Corporation of the Americas
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
Scout MD
Merit Medical Systems, Inc.
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Alphenix INFX-8000C/B5
Canon Medical System, USA, INC.
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio…
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
GRI Medical & Electronic Technology Co., Ltd.
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
SEDIPLAST
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be fo…
Olympus M3 Gold Autoclavable Lateral Telescope 70.
Olympus Corporation of the Americas
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Olympus M3 Gold Autoclavable Foroblique Telescope 30.
Olympus Corporation of the Americas
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Boston Scientific Corporation
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-th…
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-
Neuronetics, Inc.
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Glypto Device
Limitless Cryo Spa LLC
Lack of 510(k) clearance.
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF
ASP Global, LLC.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is…
SmartPath to dStream for 1.5T
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
MR 7700 and Upgrade to MR 7700
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
MR 5300
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Name
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Ingenia Elition S and Ingenia Elition X
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Ingenia 3.0T and Ingenia 3.0T CX
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Ingenia Ambition S and Ingenia Ambition X
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Ingenia 1.5T
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Evolution upgrade 1.5T and Evolution upgrade 3.0T
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Achieva XR
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Achieva 3.0T
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Achieva 1.5T
Philips North America Llc
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the…
Midmark IQvitals Zone
Midmark Corporation
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone
Midmark Corporation
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone
Midmark Corporation
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Midmark IQvitals Zone
Midmark Corporation
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
iFuse TORQ Implant System
SI-BONE, Inc.
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
Spectral CT and Spectral CT 7500 RT
PHILIPS MEDICAL SYSTEMS
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
PALACOS MV pro 40
Heraeus Medical GmbH (Dental Division)
Potential for monomer liquid leakage.
PALACOS MV+G pro 40
Heraeus Medical GmbH (Dental Division)
Potential for monomer liquid leakage.
PALACOS R+G pro 40
Heraeus Medical GmbH (Dental Division)
Potential for monomer liquid leakage.
PALACOS R pro 40
Heraeus Medical GmbH (Dental Division)
Potential for monomer liquid leakage.
EnCor EnCompass Breast Biopsy and Tissue Removal System Console
Bard Peripheral Vascular Inc
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E…
Fisher Scientific Sure-Vue Urine hCG
Alere San Diego, Inc.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Fisher Scientific Sure-Vue Urine hCG Strip
Alere San Diego, Inc.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Fisher Scientific Sure-Vue Serum/Urine hCG
Alere San Diego, Inc.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
McKesson CONSULT hCG Urine Cassette
Alere San Diego, Inc.
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
REF: 81-030415 Myocardial Probe Non-Pyrogenic
DeRoyal Industries Inc
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-760
ICU Medical, Inc.
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, expo…
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Wilson-Cook Medical Inc.
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump
Medtronic MiniMed, Inc.
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results …
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector.
Olympus Corporation of the Americas
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector.
Olympus Corporation of the Americas
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector.
Olympus Corporation of the Americas
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector.
Olympus Corporation of the Americas
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head
SEASPINE ORTHOPEDICS CORPORATION
The proximal thread depth of the spinal device is out of design specification.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11
Olympus Corporation of the Americas
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
REF:B5ST Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
REF:B5LT Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
REF:B12LT Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
REF:B11LT Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
REF:2B5ST Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
REF:2B5LT Ethicon Endo-Surgery
Stryker Sustainability Solutions
Reusable access port system may crack or seperate during use.
NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusi
BD SWITZERLAND SARL
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Presource Packs containing Medtronic Microstream Components: Intubation Kit
Cardinal Health 200, LLC
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the pati…
CHARLOTTE CLAW Screw
Wright Medical Technology, Inc.
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve…
Intrapulmonary Percussive Ventilation
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Travel Air
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Impulsator
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Intrapulmonary Percussive Ventilation
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Intrapulmonary Percussive Ventilation
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
In-Line Valve
Percussionaire Corporation
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
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Frequently asked questions
What should I do if my medical device is recalled?
Check the model and lot number against the notice and contact your doctor or the device maker before you stop using it.
Is there a recall on medical device (fda) right now?
Yes — the most recent was announced Sep 25, 2026: INTEGRATED MEDCRAFT LLC recalled FORWARD Gunshot Wound Kit. FoodRecallNow lists 3165 related recalls from the last 12 months.
Where does this recall data come from?
Directly from official U.S. government data: the FDA Enforcement Report (openFDA), USDA FSIS recalls and public health alerts, and the CPSC recalls database. Always check the official notice linked on each recall.