FDA Device recall Z-0833-2025
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile by Cook Biotech, citing incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0833-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-22 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook Biotech |
| Distribution | IN, MI |
Product
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Reason
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Identifiers
| code_info | Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559. |
|---|
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-0833-2025%22
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