CODMAN Craniotomy Kit Cranial Perforator Disposed Over Weld Defect
Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum severity score of 4. A surgical instrument disassembling during use poses risk of serious harm to a patient undergoing neurosurgery.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm (Model No. 261230) due to inadequate weld that can potentially cause the product to disassemble.
The recall affects 1,840 units that were distributed worldwide, including throughout the United States, Puerto Rico, and 62 other countries including Canada, Mexico, United Kingdom, France, Germany, Australia, Japan, and others.
Affected lot numbers include: 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. Physicians and hospitals using this equipment should contact Integra LifeSciences for instructions on device return and replacement.
The recalled product
- Product
- CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- device-disassembly
- weld-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22