Medline ReNewal Reprocessed St. Jude Medical Response recall: Particulate Matter

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

Product

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH…

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

398 units

Distribution

US Nationwide.

Recall date

September 3, 2025

Classification

Class I

Status

Ongoing

Agency

FDA (device)