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CLASS II · ModerateFDA

Medline Industries, LP recalls Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS

📅 Dec 16, 2025 · 📍 Nationwide
Recalling company
Medline Industries, LP
Product
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Reason
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 16, 2025
Reported
Jan 21, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
96 units
Lot / codes
1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-1085-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1085-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.