Integra LifeSciences Corp.: Medical Device Recall in 2023 - (Recall #: Z-0909-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Product Classification:
Class II
Date Initiated: December 2, 2022
Date Posted: January 18, 2023
Recall Number: Z-0909-2023
Event ID: 91280
Reason for Recall:
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Status: Ongoing
Product Quantity: 168 US; 3 OUS
Code Information:
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Distribution Pattern:
Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.
Voluntary or Mandated:
Voluntary: Firm initiated