Agency classClass IOur severity:Critical FDA (Devices)·Z-0373-2026·Announced 2025-11-12

Eleven millimetre cranial perforators recalled over inadequate welds

Integra LifeSciences is recalling 16,251 CODMAN Disposable Perforators, 11mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.

Plain-English summary

The CODMAN Disposable Perforator 11mm cranial perforator, model 261222, from Integra LifeSciences, is being recalled.

The action expands the recall of size 14 mm Codman Disposable Perforators for inadequate welds to the size 11 mm and 9 mm perforators, which the firm states is out of an abundance of caution.

The recall covers 16,251 units carrying UDI 10381780513612, across lots including 7221964, 7221972, 7221976, 7221977, 7221978, 7221979 and 7221980. Distribution was worldwide, including nationwide in the United States and to Argentina, Australia, Austria, the Bahamas and Barbados. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.

Facilities should quarantine affected lots immediately and follow Integra's instructions.

The recalled product

Product: CODMAN Disposable Perforator 11mm. Cranial Perforator.
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Category: Medical Device — Surgical instrument
Hazard: inadequate-weld
class-i
neurosurgery
recall-expansion
Affected units: 16,251

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. 261222
UDI: 10381780513612
Lot No. 7221964
7221972
7221976
7221977
7221978
7221979
7221980
7221981
7221982
7221983
7221984
7221985
7221986
7221987
7221988
7221989
7221990
7221991

Distribution

Distributed nationwide across the United States.

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 →

Same manufacturer · Integra LifeSciences Corp. (NeuroSciences)

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Same hazard · inadequate weld