Integra LifeSciences Corp.: Device Recall

Recall #Z-0252-2025 · 09/20/2024

Class II: Risk

Recall Details

Recall Number: Z-0252-2025
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp.
Status: Ongoing
Date Initiated: 09/20/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10719

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

Product Description

SURG STRP 1X6-200 Model/Catalog Number: 801453. 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.

Distribution Pattern

Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand Netherlands (the) Belgium France Ireland Switzerland Brunei Darussalam Bahamas (the) South Africa China Ecuador Korea (the Republic of) Czechia Kuwait Luxembourg French Guiana Mayotte Burundi Reunion Martinique Poland Costa Rica Japan Senegal Turkey Serbia Mexico Cambodia Spain Ghana Iceland Jersey Iraq Bahrain Lebanon Dominican Republic (the) Singapore Portugal Greece Austria C¿te d'Ivoire Palestine, State of Georgia Nigeria Slovenia Sweden Colombia United Arab Emirates (the) Saudi Arabia Qatar Hong Kong Oman Albania Panama Holy See (the) Kenya Pakistan Guernsey Morocco Chile Brazil Argentina Puerto Rico Rwanda Jordan Philippines (the) Hungary Romania Bolivia (Plurinational State of) Malaysia El Salvador Peru Lithuania Republic of North Macedonia Taiwan (Province of China) Israel Cyprus Bulgaria

Other Recalls by Integra LifeSciences Corp.

Class II: Risk 02/06/2025

Possibility for the obturator to break (separate).
Class II: Risk 01/10/2025

Potential that the induction seal is not completely sealed to the device tube packaging.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.