Integra LifeSciences Corp. Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Products Sold
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Integra LifeSciences Corp. is recalling Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 due to Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Sur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 2, 2022, the firm notified customers via "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letters. Customers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026