The Recall Desk
HighFDA (Devices)·Z-0373-2026·Announced 2025-11-12

[pending] CODMAN Disposable Perforator 11mm. Cranial Perforator.

Pending LLM rewrite. Source: FDA_DEVICE Z-0373-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

The recalled product

Product
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Manufacturer
Integra LifeSciences Corp. (NeuroSciences)

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.