MICR PATIE RND Model/Catalog Number: 801396 — Class II medical device recall Z-0235-2025
Ongoing recall by Integra LifeSciences Corp., reported 2024-11-06, distributed nationwide. Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Pa
| Recall number | Z-0235-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-09-20 |
| Classified | 2024-10-29 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, EC, ES, FR, GB, GH, GR, HK, HU, IE, IL, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LT, LU, MA, MT, MX, MY, NG, NL, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SV, TR, TT, TW, ZA |
| Quantity | 1,791 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10381780514923, 20886704036446 |
| Model numbers | 801396 |
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 for recall
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
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-0235-2025. 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.