FDA Device recall Z-0246-2025
SURG PAT XRAY 1X3 Model/Catalog Number: 801408
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of SURG PAT XRAY 1X3 Model/Catalog Number: 801408 by Integra Lifesciences, citing identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification level….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0246-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-20 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Reason
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Identifiers
| code_info | UDI-DI: 10381780515036, 20886704036552 Note: the same product code was distributed for a few years under JnJ under a t…UDI-DI: 10381780515036, 20886704036552 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products. |
|---|
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-0246-2025%22
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