CODMAN Disposable Perforator 9mm. Cranial Perforator.
Summary
The FDA issued a Class I for CODMAN Disposable Perforator 9mm. Cranial Perforator. by Integra LifeSciences Corp. (NeuroSciences). Reason: 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 ab.
Details
Source
Device Recall
External ID
Z-0374-2026
Action Date
2025-11-12
Status
Ongoing
Category
device
Product Description
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Lot/Code Info: 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.
Quantity Affected: 5,109 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-26
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp. (NeuroSciences)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. (NeuroSciences) have FDA actions?
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0374-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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