CLASS I ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

Codman Craniotomy Kit, Disposable Perforator Cranio-blade recalled

Integra LifeSciences Corp. (NeuroSciences) is recalling Codman Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill Cranial, distributed nationwide in the US. The recall was initiated on 11 Apr 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel No. 261230; UDI: 10381780513629; Lot No. Lot Number, 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, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.

Quantity recalled1,840 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1717-2025
FDA event ID: 96694
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Classification: Class I
Status: Ongoing
Recall initiated: 11 Apr 2025
FDA classified: 6 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Apr 2025	Recall initiated by company
6 May 2025	Classified by FDA	+25 days
14 May 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Inadequate weld that can potentially cause the product to disassemble.

Product as listed by the FDA

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

Where it was distributed

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.

Nationwide Puerto Rico

Stores named: Walmart

Questions about this recall

Is Codman Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill Cranial recalled?

Yes. Integra LifeSciences Corp. (NeuroSciences) recalled Codman Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill Cranial on 11 Apr 2025. The recall is Class I and its status is Ongoing. Recall number Z-1717-2025.

Why was it recalled?

Inadequate weld that can potentially cause the product to disassemble.

Which lots are affected?

Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 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, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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