FDA Device recall Z-0235-2025
MICR PATIE RND Model/Catalog Number: 801396
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of MICR PATIE RND Model/Catalog Number: 801396 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-0235-2025 |
| 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
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. 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 | Lot Code: UDI# 10381780514923, 20886704036446 Note: the same product code was distributed for a few years under JnJ un…Lot Code: UDI# 10381780514923, 20886704036446 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-0235-2025%22
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