Home / Recalls / Integra LifeSciences Corp. / Z-0255-2025

Z-0255-2025 Class II Ongoing

Recalled by Integra LifeSciences Corp. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
November 6, 2024
Initiation Date
September 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1454 units

Product Description

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.

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

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

Code Information

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.

Other recalls by Integra LifeSciences Corp.

  • Z-1295-2025 Class II — AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obt (February 6, 2025)
  • Z-1168-2025 Class II — Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel (January 10, 2025)
  • Z-0978-2025 Class II — CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828 (December 16, 2024)
  • Z-0977-2025 Class II — CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828 (December 16, 2024)
  • Z-0979-2025 Class II — CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8288 (December 16, 2024)
  • Z-0262-2025 Class II — Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 (September 26, 2024)
  • Z-0252-2025 Class II — SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgic (September 20, 2024)
  • Z-0251-2025 Class II — SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical (September 20, 2024)
  • Z-0250-2025 Class II — SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgica (September 20, 2024)
  • Z-0238-2025 Class II — SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and s (September 20, 2024)