Medline ReNewal Reprocessed St — Class I medical device recall Z-2460-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-09-03, distributed nationwide. Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

Recall number	`Z-2460-2025`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2025-07-14
Classified	2025-08-28
Reported by FDA	2025-09-03
Distributed	Nationwide (US)
Quantity	398 units
Reason classes	specification failure
UPC / GTIN / UDI-DI	`10197344043439`, `10197344043453`, `10197344043460`, `10197344043477`, `10197344043484`, `10197344043491`, `10197344043521`, `10197344043545`, `10197344043569`, `10197344043613`, `10197344043637`, `10197344043651`, `10197344043668`, `10197344043682`, `10197344043699`, `10197344043705`, `10197344043712`, `10197344043736`, `10197344043835`, `10197344044245`, `10197344044252`, `10197344044269`, `10197344044283`, `10197344044290`, `10197344044306` and 14 more
Lot numbers	`EP241118`, `EP250106`
Model numbers	`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` and 46 more

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2460-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.