Medline ReNewal Reprocessed Livewire Steerable Electrophysiology… — Class II medical device recall Z-1460-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-02, distributed nationwide. Devices may have higher than expected amounts of bacterial endotoxin.
| Recall number | Z-1460-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-03-26 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 74 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 10888277407510, 10888277407602, 10888277407688, 10888277407756, 20888277407517, 20888277407609, 20888277407616, 20888277407685, 20888277407753 |
| Lot numbers | 401904R, 401905R, 401933R, 401991R, EP240528, EP240805 |
| Model numbers | 401582R, 401904R, 401905R, 401933R, 401991R |
Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Reason for recall
Devices may have higher than expected amounts of bacterial endotoxin.
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-1460-2025. 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.