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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 Risk of Disassembly During Surgery

Agency Publication Date: May 6, 2025
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Summary

Integra LifeSciences is recalling approximately 172,350 units of the CODMAN Disposable Perforator and Craniotomy Kit due to a manufacturing defect. The tools, which are used to drill through the skull during neurosurgery, may have an inadequate weld that could cause the product to break or come apart while being used by a surgeon. While no injuries have been reported to date, this voluntary recall was initiated to prevent potential surgical complications or delays.

Risk

The cranial perforator may disassemble during surgery due to a weak weld. If the device breaks apart while in use, it could lead to surgical delays or pose a risk of injury to the patient during delicate brain procedures.

What You Should Do

  1. This recall involves the CODMAN Disposable Perforator (Model 261221) and the CODMAN Craniotomy Kit (Model 261230) used in surgical procedures.
  2. To determine if your unit is affected, check the model number and lot number printed on the product label or packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately and remove any affected units from your surgical inventory.
  4. Contact Integra LifeSciences Corp. or your authorized medical supply distributor to arrange for the return, replacement, or correction of the affected products.
  5. Call the FDA: 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

📋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, 14mm (Cranial perforator)
Variants: 14mm
Model / REF:
261221
Lot Numbers (3391):
5580821
5664307
6347547
6566289
6589889
6715286
6715287
6756578
6756631
6757665
6899419
6910166
7008982
7008995
7009033
7009035
7009166
7009167
7092837
7093002
7124525
7195332
7195376
7195380
7230293
7230295
7230296
7230430
7230431
7230437
7230439
7230440
7230441
7230442
7230443
7230444
7230445
7230446
7230447
7230448
7230449
7230450
7230451
7230452
7230453
7230454
7230455
7230456
7230457
7230458
UDI:
10381780513599

Quantity: 170,510 units

Product: CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm (Cranial perforator kit)
Variants: 14mm
Model / REF:
261230
Lot Numbers (56):
5984530
7062002
7062006
7062013
7062014
7255930
7255931
7255932
7255933
7255934
7255935
7255936
7255937
7269522
7269523
7269524
7269525
7282944
7282945
7282946
7282948
7282949
7282950
7282951
7282952
7282953
7293408
7293409
7293410
7293411
7293412
7293413
7293414
7322892
7322893
7322894
7322895
7322896
7322897
7322898
7332664
7332665
7332666
7332667
7332668
7348744
7348745
7348746
7348747
7348748
UDI:
10381780513629

Quantity: 1,840 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96694
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: authorized distributors; medical supply channels
Manufactured In: United States
Units Affected: 2 products (170,510 units; 1,840 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 · 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.