CODMAN recallZ-0909-2023 · Integra LifeSciences Corp. · initiated Dec 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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: [email protected]
Recall details
- Recall number
- Z-0909-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 2, 2022
- Posted by the FDA
- Jan 6, 2023
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 168 US; 3 OUS
- Product code
- HBA
- FDA submissions
- K193346
- Distribution
- 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.
Product description
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Code information (models, lots, serial numbers)
UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K193346 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CODMAN® 245404Integra Lifesciences Production Corporation · Neurosurgical paddie10 reports
- CODMAN® 245431Integra Lifesciences Production Corporation · Neurosurgical paddie2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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