FDA Device recall Z-0909-2023
Codman Surgical Patties, Part number 801400
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Codman Surgical Patties, Part number 801400 by Integra Lifesciences, citing integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0909-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-02 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Reason
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Identifiers
| code_info | UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0909-2023%22
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