Medline Industries, LP recalls Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH
- Recalling company
- Medline Industries, LP
- Product
- Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
- Reason
- Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 15, 2026
- Reported
- Jul 8, 2026
- Distribution
- US Nationwide distribution in the state of TX.
- Status
- Ongoing
- Quantity
- 3
- Lot / codes
- Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
- Company location
- Northfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2615-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2615-2026 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.