The Recall Desk
SevereFDA (Devices)·Z-1717-2025·Announced 2025-05-14

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)
Category
Medical Device — Surgical / Neurosurgical Equipment
Hazard
Affected units
1,840

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Integra LifeSciences Corp. (NeuroSciences) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Integra LifeSciences Corp. (NeuroSciences)

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Same hazard · device disassembly

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