Integra LifeSciences Corp. (NeuroSciences) medical device recall: CODMAN Disposable Perforator
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96694
- Recall initiated
- Apr 11, 2025
- Classified by FDA
- May 6, 2025
- Posted in Enforcement Report
- May 14, 2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Firm location
- Princeton, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Inadequate weld that can potentially cause the product to disassemble.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 11, 2025. FDA classified it 25 days later, on May 6, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… Integra LifeSciences Corp. (NeuroSciences) has 13 recalls in our records.
Recalled products (2)
Z-1716-2025 Class I Ongoing
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Codes / lots: 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,…
Quantity: 170,510 units
Z-1717-2025 Class I Ongoing
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Codes / lots: Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 5984530, 7062002, 7062006, 7062013, 7062014, 7255930, 7255931, 7255932, 7255933, 7255934, 7255935, 7255936, 7255937, 7269522, 7269523, 7269524, 7269525, 7282944, 7282945, 7282946, 7282948, 7282949, 7282950, 7282951, 7282952, 7282953, 7293408, 7293409, 7293410, 7293411, 7293412, 7293413, 7293414, 7322892, 7322893, 7322894, 7322895, 7322896, 7322897, 7322898, 7332664, 7332665, 7332666, 7332667, 7332668, 7348744, 7348745, 7348746, 7348747, 7348748, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.
Quantity: 1,840 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96694
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.