FDA Device recall Z-2610-2025
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165…
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165… by Medline Industries, citing specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2610-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-31 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | US |
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
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.
Identifiers
| code_info | Item Number/UDI (ea)/UDI(case): 401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600…Item Number/UDI (ea)/UDI(case): 401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600RH 10888277407541 20888277407548; 401603RH 10888277407558 20888277407555; 401606RH 10888277407565 20888277407562; 401652RH 10888277407572 20888277407579; 401653RH 10888277407589 20888277407586; 401654RH 10888277407596 20888277407593; 401904RH 10888277407602 20888277407609; 401905RH 10888277407619 20888277407616; 401908RH 10197344020966 20197344020963; 401914RH 10888277407527 20888177407524; 401915RH 10888277407626 20888277407623; 401918RH 10888277407640 20888277407647; 401932RH 10888277407671 20888277407678; 401933RH 10888277407688 20888277407685; 401934RH 10888277407695 20888277407692; 401938RH 10888277407701 20888277407708; 401939RH 10888277407718 20888277407715; 401940RH 10888277407480 20888277407487; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753; LOTS EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2610-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.