FDA Device recall Z-1760-2025
Centerline Biomedical IOPS Guidewire 2, REF ATW-2
- FDA Device
- Class I
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class I recall of Centerline Biomedical IOPS Guidewire 2, REF ATW-2 by Centerline Biomedical, citing centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1760-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-11 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Centerline Biomedical |
| Distribution | FL, NC, NM, NY, PA, TN, TX, VA |
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reason
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Identifiers
| code_info | UDI/DI 00843152102037, Lot Number 2404-2005 |
|---|
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-1760-2025%22
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