CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Recall #Z-0374-2026 — Class I — September 26, 2025
Product Description
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Reason for Recall
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.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
5,109 units
Distribution
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, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
Code Information
Model No. 261223; UDI: 10381780513605; Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279; Expiration Date: 2024-03-31 to 2029-07-31.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated