FDA Medical devices recall ·
SURG STRP 3X6 Model recall
- Recall number
- Z-0255-2025
- Date
- (initiated September 20, 2024)
- Company / brand
- Integra LifeSciences Corp.
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1454 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SURG STRP 3X6 Model/Catalog Number: 801456. 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.
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10381780515128, 20886704036644 480 974 1454 Note: the same product code was distributed for a few years under JnJ under a transition agreement with Integra. Therefore, 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Distribution
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
States: Georgia Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0255-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.