CLASS I ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

Medline ReNewal Reprocessed St. Jude Medical Response recalled

Medline Industries LP - Northfield is recalling Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic, distributed nationwide in the US. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118; 18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP250106; 19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP241118; 20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP250106; 21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case), Lot Number: EP241118; 22) 401434RH, UDI-DI: 10197344043477(each), 10197344043477(case), Lot Number: EP241118; 23) 401435RH, UDI-DI: 10197344043460(each), 10197344043460(case), Lot Number: EP241118; 24) 401436RH, UDI-DI: 10197344043453(each), 10197344043453(case), Lot Number: EP250106; 25) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP241118; 26) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP250106; 27) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP241118; 28) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP250106; 29) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP241118; 30) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP250106; 31) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP241118; 32) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP250106; 33) 401448RH, UDI-DI: 10197344044283(each), 10197344044283(case), Lot Number: EP250106; 34) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP241118; 35) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP250106; 36) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP241118; 37) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP250106; 38) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP241118; 39) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP250106; 40) 401453RH, UDI-DI: 10197344044320(each), 10197344044320(case), Lot Number: EP250106; 41) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP241118; 42) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP250106; 43) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP241118; 44) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP250106; 45) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP241118; 46) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP250106; 47) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP241118; 48) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP250106; 49) 401877RH, UDI-DI: 10197344044436(each), 10197344044436(case), Lot Number: EP241118; 50) 401878RH, UDI-DI: 10197344044443(each), 10197344044443(case), Lot Number: EP241118; 51) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP241118; 52) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP250106; 53) 401891RH, UDI-DI: 10197344044467(each), 10197344044467(case), Lot Number: EP241118; 54) 401966RH, UDI-DI: 10197344044498(each), 10197344044498(case), Lot Number: EP250106; 55) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP241118; 56) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP250106; 57) 402008RH, UDI-DI: 10197344044573(each), 10197344044573(case), Lot Number: EP241118; 58) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP241118; 59) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP250106; 60) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP241118; 61) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP250106

Quantity recalled398 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2460-2025
FDA event ID: 97357
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 14 Jul 2025
FDA classified: 28 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

14 Jul 2025	Recall initiated by company
28 Aug 2025	Classified by FDA	+45 days
3 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

Product as listed by the FDA

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

Which lots are affected?

1) 401211RH, UDI-DI: 10197344043736(each), 10197344043736(case), Lot Number: EP250106; 2) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP241118; 3) 401222RH, UDI-DI: 10197344043712(each), 10197344043712(case), Lot Number: EP250106; 4) 401223RH, UDI-DI: 10197344043705(each), 10197344043705(case), Lot Number: EP250106; 5) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP241118; 6) 401226RH, UDI-DI: 10197344043699(each), 10197344043699(case), Lot Number: EP250106; 7) 401227RH, UDI-DI: 10197344043682(each), 10197344043682(case), Lot Number: EP250106; 8) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP241118; 9) 401260RH, UDI-DI: 10197344043668(each), 10197344043668(case), Lot Number: EP250106; 10) 401261RH, UDI-DI: 10197344043651(each), 10197344043651(case), Lot Number: EP250106; 11) 401305RH, UDI-DI: 10197344043637(each), 10197344043637(case), Lot Number: EP250106; 12) 401309RH, UDI-DI: 10197344043613(each), 10197344043613(case), Lot Number: EP250106; 13) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP241118; 14) 401353RH, UDI-DI: 10197344043569(each), 10197344043569(case), Lot Number: EP250106; 15) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP241118; 16) 401381RH, UDI-DI: 10197344043545(each), 10197344043545(case), Lot Number: EP250106; 17) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP241118; 18) 401399RH, UDI-DI: 10197344043521(each), 10197344043521(case), Lot Number: EP250106; 19) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP241118; 20) 401430RH, UDI-DI: 10197344043491(each), 10197344043491(case), Lot Number: EP250106; 21) 401433RH, UDI-DI: 10197344043484(each), 10197344043484(case), Lot Number: EP241118; 22) 401434RH, UDI-DI: 10197344043477(each), 10197344043477(case), Lot Number: EP241118; 23) 401435RH, UDI-DI: 10197344043460(each), 10197344043460(case), Lot Number: EP241118; 24) 401436RH, UDI-DI: 10197344043453(each), 10197344043453(case), Lot Number: EP250106; 25) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP241118; 26) 401441RH, UDI-DI: 10197344043439(each), 10197344043439(case), Lot Number: EP250106; 27) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP241118; 28) 401442RH, UDI-DI: 10197344044245(each), 10197344044245(case), Lot Number: EP250106; 29) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP241118; 30) 401443RH, UDI-DI: 10197344044252(each), 10197344044252(case), Lot Number: EP250106; 31) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP241118; 32) 401444RH, UDI-DI: 10197344044269(each), 10197344044269(case), Lot Number: EP250106; 33) 401448RH, UDI-DI: 10197344044283(each), 10197344044283(case), Lot Number: EP250106; 34) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP241118; 35) 401449RH, UDI-DI: 10197344044290(each), 10197344044290(case), Lot Number: EP250106; 36) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP241118; 37) 401450RH, UDI-DI: 10197344044306(each), 10197344044306(case), Lot Number: EP250106; 38) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP241118; 39) 401451RH, UDI-DI: 10197344044313(each), 10197344044313(case), Lot Number: EP250106; 40) 401453RH, UDI-DI: 10197344044320(each), 10197344044320(case), Lot Number: EP250106; 41) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP241118; 42) 401474RH, UDI-DI: 10197344044351(each), 10197344044351(case), Lot Number: EP250106; 43) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP241118; 44) 401860RH, UDI-DI: 10197344044382(each), 10197344044382(case), Lot Number: EP250106; 45) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP241118; 46) 401863RH, UDI-DI: 10197344044399(each), 10197344044399(case), Lot Number: EP250106; 47) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP241118; 48) 401864RH, UDI-DI: 10197344044405(each), 10197344044405(case), Lot Number: EP250106; 49) 401877RH, UDI-DI: 10197344044436(each), 10197344044436(case), Lot Number: EP241118; 50) 401878RH, UDI-DI: 10197344044443(each), 10197344044443(case), Lot Number: EP241118; 51) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP241118; 52) 401890RH, UDI-DI: 10197344044450(each), 10197344044450(case), Lot Number: EP250106; 53) 401891RH, UDI-DI: 10197344044467(each), 10197344044467(case), Lot Number: EP241118; 54) 401966RH, UDI-DI: 10197344044498(each), 10197344044498(case), Lot Number: EP250106; 55) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP241118; 56) 402004RH, UDI-DI: 10197344044566(each), 10197344044566(case), Lot Number: EP250106; 57) 402008RH, UDI-DI: 10197344044573(each), 10197344044573(case), Lot Number: EP241118; 58) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP241118; 59) 402010RH, UDI-DI: 10197344044597(each), 10197344044597(case), Lot Number: EP250106; 60) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP241118; 61) 402012RH, UDI-DI: 10197344043835(each), 10197344043835(case), Lot Number: EP250106

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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