The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1716-2025·Announced 2025-05-14

CODMAN Disposable Cranial Perforator 14mm Recalled Due Weld Issue

Integra LifeSciences is recalling CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. The inadequate weld could cause failure of a surgical instrument during a cranial procedure, presenting a serious safety risk even though no injuries are reported in the source text.

Plain-English summary

Integra LifeSciences Corp. (NeuroSciences) is recalling the CODMAN Disposable Perforator, 14mm (Model No. 261221), a cranial surgical perforator. The recall is due to an inadequate weld that can potentially cause the product to disassemble.

The affected devices have been distributed worldwide, including the United States and Puerto Rico, as well as 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, 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, and the United Kingdom. Approximately 170,510 units are involved in this recall.

Healthcare facilities and individuals in possession of affected CODMAN Disposable Perforators should stop using these devices immediately and contact Integra LifeSciences for instructions regarding returns or replacement. Users should check lot numbers to determine if their units are among those affected by this recall.

The recalled product

Product
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Manufacturer
Integra LifeSciences Corp. (NeuroSciences)
Category
Medical Device — Surgical Instrument / Cranial
Hazard
Affected units
170,510

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. 261221
  • UDI 10381780513599
  • Lot No. Lot Number
  • 5580821
  • 5664307
  • 6347547
  • 6566289
  • 6589889
  • 6715286
  • 6715287
  • 6756578
  • 6756631
  • 6757665
  • 6899419
  • 6910166
  • 7008982
  • 7008995
  • 7009033
  • 7009035
  • 7009166

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 · weld failure

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