Class I — Centerline Biomedical Inc
| Recalling firm | Centerline Biomedical |
|---|---|
| Registered facility | CENTERLINE BIOMEDICAL (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. |
| Product | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter |
| Quantity | 80 units |
| Distribution | US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee |
| Initiated | 2025-04-11 |
| Classified | 2025-05-19 |
| Recall number | Z-1760-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Centerline Biomedical Inc (Z-1760-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96697/
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