Recall
FDAHealthJuly 14, 2025

MEDLINE INDUSTRIES, LP - Northfield — Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH,

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 14, 2025

US Nationwide.

What's affected?

Product
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
Lot code
EP250106

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 398 units.

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