Reprocessed Livewire Steerable Electrophysiology Catheter Item… — Class I medical device recall Z-2610-2025
Ongoing recall by Medline Industries, LP, reported 2025-10-08, distributed nationwide. Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulate
| Recall number | Z-2610-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-07-31 |
| Classified | 2025-09-26 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 7,913 eaches |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10197344020966, 10888277407480, 10888277407497, 10888277407510, 10888277407527, 10888277407541, 10888277407558, 10888277407565, 10888277407572, 10888277407589, 10888277407596, 10888277407602, 10888277407619, 10888277407626, 10888277407640, 10888277407671, 10888277407688, 10888277407695, 10888277407701, 10888277407718, 10888277407725, 10888277407756, 20197344020963, 20888277407487, 20888277407494 and 17 more |
| Lot numbers | EP230724, EP230731, EP230803, EP230816, EP230914, EP231017, EP231116, EP240108, EP240122, EP240212, EP240227, EP240311, EP240322, EP240411, EP240415, EP240422, EP240429, EP240507, EP240514, EP240520, EP240528, EP240607, EP240611, EP240710, EP240715, EP240723, EP240805, EP240812, EP240820, EP240829, EP240911, EP240923, EP240930, EP241008, EP241030, EP241125, EP250108 |
| Model numbers | 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH, 401904RH, 401905RH, 401908RH, 401914RH, 401915RH, 401918RH, 401932RH, 401933RH, 401934RH, 401938RH, 401939RH, 401940RH, 401941RH, 401991RH |
Product
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH
Reason for recall
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
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-2610-2025. 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.