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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Codman Disposable Perforators Recalled for Inadequate Welds

Agency Publication Date: November 3, 2025
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Summary

Integra LifeSciences Corp. is recalling Codman Disposable Perforators in 11mm and 9mm sizes because they may have inadequate welds. This recall expands a previous action for the 14mm model and affects 21,360 units worldwide. These devices are used by surgeons to create small holes in the skull during cranial procedures.

Risk

Inadequate welds could cause the perforator to fail or malfunction during surgery. This may lead to surgical delays, potential injury to the patient, or the need for additional procedures.

What You Should Do

  1. This recall affects Codman Disposable Perforators in 11mm (Model 261222) and 9mm (Model 261223) sizes with expiration dates ranging from March 2024 through July 2029.
  2. Check the model number and lot number printed on the device packaging to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CODMAN Disposable Perforator 11mm. Cranial Perforator.
Variants: 11mm
Model / REF:
261222
Lot Numbers (199):
7221964
7221972
7221976
7221977
7221978
7221979
7221980
7221981
7221982
7221983
7221984
7221985
7221986
7221987
7221988
7221989
7221990
7221991
7230624
7230625
7230626
7230627
7230628
7230629
7230630
7230631
7230632
7230633
7230634
7230635
7230636
7230637
7230638
7230639
7230640
7230641
7230642
7230643
7230644
7230645
7230646
7230647
7230648
7230649
7230650
7230651
7230652
7230653
7230654
7230655
UDI:
10381780513612
Date Ranges: Expiration Date: 2028-04-30 to 2029-07-31

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds.

Product: CODMAN Disposable Perforator 9mm. Cranial Perforator.
Variants: 9mm
Model / REF:
261223
Lot Numbers (63):
5828553
6264478
6264481
6264482
7230672
7230673
7230674
7230675
7261971
7268008
7268009
7268010
7268011
7268012
7268013
7268014
7268015
7268016
7268017
7268018
7268019
7282954
7282955
7293422
7293423
7293424
7293425
7293426
7293427
7293428
7300667
7300668
7300669
7300670
7300672
7300673
7300674
7371082
7371083
7379652
7379922
7379923
7379924
7379926
7379928
7379660
7379925
7379927
7450559
7450560
UDI:
10381780513605
Date Ranges: Expiration Date: 2024-03-31 to 2029-07-31

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97623
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 2 products (16,251 units; 5,109 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.