Centerline Biomedical IOPS Guidewire 2 — Class I medical device recall Z-1760-2025
Ongoing recall by Centerline Biomedical Inc, reported 2025-05-28, distributed in FL, NC, NM, NY, PA, TN, TX, VA. Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate durin
| Recall number | Z-1760-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Centerline Biomedical Inc, Cleveland, OH, United States |
| Recall initiated | 2025-04-11 |
| Classified | 2025-05-19 |
| Reported by FDA | 2025-05-28 |
| Distributed | FL, NC, NM, NY, PA, TN, TX, VA |
| Countries outside the US | MX |
| Quantity | 80 units |
| UPC / GTIN / UDI-DI | 00843152102037 |
| Lot numbers | 2404-2005 |
| Model numbers | ATW-2 |
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reason for recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
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-1760-2025. 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.