SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397 — Class II medical device recall Z-0236-2025

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-0236-2025`
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	2,615
Reason classes	sterility
UPC / GTIN / UDI-DI	`10381780514930`, `20886704036453`
Model numbers	`801397`

Product

SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. 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-0236-2025. 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.