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

Recall date

September 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0373-2026

FDA classification

Class I

Brand / firm

Integra LifeSciences Corp. (NeuroSciences)

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherl…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CODMAN Disposable Perforator 11mm. Cranial Perforator.