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U.S. Department of Health and Human Services

Class 1 Device Recall St. Jude Supreme and Response Diagnostic Electrophysiology Catheters

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 Class 1 Device Recall St. Jude Supreme and Response Diagnostic Electrophysiology Catheterssee related information
Date Initiated by FirmDecember 22, 2025
Date PostedFebruary 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1322-2026
Recall Event ID 98277
510(K)NumberK241156 
Product Classification Catheter, recording, electrode, reprocessed - Product Code NLH
ProductReprocessed 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 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
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce48
DistributionDistribution US nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NLH
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