FDA-Device2025-11-12Class IPROCESSING DEFECT
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
16,251 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0373-2026Want us to check the next one for you?
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