Medline Industries, LP recalls Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St…
Reason for recall
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
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 10197344043736
- Lot #
- EP250317; 401222RH
- UDI
- 10197344043712
- Lot #
- EP250317; 401223RH
- UDI
- 10197344043705
- Lot #
- EP250317; 401226RH
- UDI
- 10197344043699
- Lot #
- EP250307 EP250317; 401227RH
- UDI
- 10197344043682 Lots EP250307 EP250317; 401260RH
- UDI
- 10197344043668
- Lot #
- EP250317; 401261RH
- UDI
- 10197344043651
- Lot #
- EP250317; 401306RH
- UDI
- 10197344043620¿
- Lot #
- EP250317; 401309RH
- UDI
- 10197344043613
- Lot #
- EP250317; 401312RH
- UDI
- 10197344043583¿
- Lot #
- EP250307; 401430RH
- UDI
- 10197344043491 Lots EP250307 EP250317; 401433RH
- UDI
- 10197344043484 Lots EP250307 EP250317; 401435RH
- UDI
- 10197344043460 Lots EP250307 EP250317; 401441RH
- UDI
- 10197344043439 Lots EP250307 EP250317; 401442RH
- UDI
- 10197344044245
- Lot #
- EP250307; 401443RH
- UDI
- 10197344044252 Lots EP250307 EP250317; 401448RH
- UDI
- 10197344044283
- Lot #
- EP250307; 401449RH
- UDI
- 10197344044290
- Lot #
- EP250307; 401450RH
- UDI
- 10197344044306 Lots EP250307 EP250317; 401451RH
- UDI
- 10197344044313 EP250307 EP250317; 401474RH
- UDI
- 10197344044351
- Lot #
- EP250307; 401860RH
- UDI
- 10197344044382 Lots EP250307 EP250317; 401877RH
- UDI
- 10197344044436 Lots EP250307 EP250317; 401878RH
- UDI
- 10197344044443
- Lot #
- EP250307; 401890RH
- UDI
- 10197344044450 Lots EP250307 EP250317; 401891RH
- UDI
- 10197344044467
- Lot #
- EP250307; 401994RH
- UDI
- 10197344044542
- Lot #
- EP250317; 402012RH
- UDI
- 10197344043835 Lots EP250307 EP250317; 402004RH
- UDI
- 10197344044566 Lots EP250307 EP250317; 402010RH
- UDI
- 10197344044597 Lots EP250307 EP250317; 402008RH
- UDI
- 10197344044573
- Lot #
- EP250317; 402009RH
- UDI
- 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 4018…Show all
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
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What the firm 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.
DistributionShow detailsHide
Distribution US nationwide.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1322-2026
- FDA 510(k) clearance · K241156The device's official FDA premarket clearance record
- FDA device classification · NLHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1220The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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