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Reprocessed St. Jude Supreme and Response Diagnostic… recallZ-1322-2026 · Medline Industries, LP · initiated Dec 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.

Recall details

Recall number
Z-1322-2026
Status
Open, Classified
Initiated by the company
Dec 22, 2025
Posted by the FDA
Feb 6, 2026
Recalling firm
Medline Industries, LP
Quantity
48
Product code
NLH
FDA submissions
K241156
Distribution
Distribution US nationwide.

Product description

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: 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; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

401211RH UDI-DI 10197344043736 Lot EP250317; 401222RH UDI-DI 10197344043712 Lot EP250317; 401223RH UDI-DI 10197344043705 Lot EP250317; 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 Lot EP250317; 401261RH UDI-DI 10197344043651 Lot EP250317; 401306RH UDI-DI 10197344043620¿ Lot EP250317; 401309RH UDI-DI 10197344043613 Lot EP250317; 401312RH UDI-DI 10197344043583¿ Lot 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 Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 Lot EP250307; 401449RH UDI-DI 10197344044290 Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 Lot EP250307; 401994RH UDI-DI 10197344044542 Lot 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 Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317 ***Updated 5/18/26*** 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

Devices named in this recall

32 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

8 devices cleared under K241156 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98277).

Sources and updates

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