Codman Surgical Patties — Class II medical device recall Z-0909-2023
Ongoing recall by Integra LifeSciences Corp., reported 2023-01-18, distributed nationwide. Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The wor
| Recall number | Z-0909-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2022-12-02 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, FR, GB, IE, NZ, RO |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780514961 |
| Lot numbers | 6396457 |
| Model numbers | 801400 |
| Expiration dates | 2027-06-30 |
Product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0909-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.