Recall archive / FDA device enforcement

CODMAN Disposable Perforator, 14mm. Cranial perforator. — FDA record Z-1716-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CODMAN Disposable Perforator, 14mm. Cranial perforator.
Reason: Inadequate weld that can potentially cause the product to disassemble.
Classification: Class I
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Quantity: 170,510 units
Agency-reported status: Ongoing
Source record identifier: Z-1716-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model No. 261221; UDI 10381780513599; Lot No. Lot Number, 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448, 7230449, 7230450, 7230451, 7230452, 7230453, 7230454, 7230455, 7230456, 7230457, 7230458, 7230459, 7230460, 7230461, 7230462, 7230463, 7230464, 7230465, 7230466, 7230467, 7230468, 7230471, 7230472, 7230473, 7230474, 7230475, 7230476, 7230477, 7230478, 7230479, 7230480, 7230481, 7230482, 7230483, 7230484, 7230485, 7230486, 7230487, 7230488, 7230489, 7230490, 7230491, 7230492, 7230493, 7230494, 7230495, 7230496, 7230497, 7230498, 7230499, 7230500, 7230501, 7230502, 7230503, 7230504, 7230505, 7230506, 7230507, 7230508, 7230509, 7230510, 7230511, 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Label field

Details supplied by the agency

Lot, code or applicability

Model No. 261221; UDI 10381780513599; Lot No. Lot Number, 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448, 7230449, 7230450, 7230451, 7230452, 7230453, 7230454, 7230455, 7230456, 7230457, 7230458, 7230459, 7230460, 7230461, 7230462, 7230463, 7230464, 7230465, 7230466, 7230467, 7230468, 7230471, 7230472, 7230473, 7230474, 7230475, 7230476, 7230477, 7230478, 7230479, 7230480, 7230481, 7230482, 7230483, 7230484, 7230485, 7230486, 7230487, 7230488, 7230489, 7230490, 7230491, 7230492, 7230493, 7230494, 7230495, 7230496, 7230497, 7230498, 7230499, 7230500, 7230501, 7230502, 7230503, 7230504, 7230505, 7230506, 7230507, 7230508, 7230509, 7230510, 7230511, 7230512, 7230513, 7230514, 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7289185, 72891...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: May 14, 2025
Recall initiation date: Apr 11, 2025
Center classification date: May 6, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records