Reported Feb 18, 2026 · Ongoing
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters
Medline Industries, LP
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters
5 of 5 products
| # | Product as published |
|---|---|
| 1 | St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH |
| 2 | St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH |
| 3 | St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH |
| 4 | St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH |
| 5 | St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH |
- Lot codes and dates
18 of 18 products
Products covered by this recall # Barcodes Product as published 1 10197344043712Lot EP250317; 401222RH UDI-DI 10197344043712 2 10197344043705Lot EP250317; 401223RH UDI-DI 10197344043705 3 10197344043699Lot EP250317; 401226RH UDI-DI 10197344043699 4 1019734404368210197344043668Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 5 10197344043651Lot EP250317; 401261RH UDI-DI 10197344043651 6 10197344043620Lot EP250317; 401306RH UDI-DI 10197344043620¿ 7 10197344043613Lot EP250317; 401309RH UDI-DI 10197344043613 8 10197344043583Lot EP250317; 401312RH UDI-DI 10197344043583¿ 9 1019734404349110197344043484101973440434601019734404343910197344044245Lot EP250307; 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317; 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317; 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317; 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317; 401442RH UDI-DI 10197344044245 10 1019734404425210197344044283Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 11 10197344044290Lot EP250307; 401449RH UDI-DI 10197344044290 12 101973440443061019734404431310197344044351Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 13 101973440443821019734404443610197344044443Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 14 1019734404445010197344044467Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 15 10197344044542Lot EP250307; 401994RH UDI-DI 10197344044542 16 10197344043835101973440445661019734404459710197344044573Lot EP250317; 402012RH UDI-DI 10197344043835 Lots EP250307 EP250317; 402004RH UDI-DI 10197344044566 Lots EP250307 EP250317; 402010RH UDI-DI 10197344044597 Lots EP250307 EP250317; 402008RH UDI-DI 10197344044573 17 10197344044580Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317 ***Updated 5/18/26*** 18 LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH - Amount recalled
- 48
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Using this product could cause serious injury, illness or death — stop using it now.
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