Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator
Reason for recall
Inadequate weld that can potentially cause the product to disassemble.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Lot / code information
- Model
- 261221
- UDI
- 10381780513599
- Lot #
5580821, 5664307, 6347547, 6566289, 6589889, 6715286 — +3386 moreShow all
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7265 …
What the firm is doing
An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification, dated 4/11/25, was distributed to consignees via mail and email. Consignees are being asked to check their inventory for affected devices and immediately quarantine any product identified. Consignees are asked to complete the provided Acknowledgement Form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220; all consignees are to complete and return the form. Integra asks that the recall notification be forwarded to all users of the devices and to customers who received product that was further distributed. Distributors are to collect completed Acknowledgement Forms from their customers and provide them to the firm. Consignees with any questions can contact Customer Service at 1-800-654-2873 or by email at custsvcnj@integralife.com.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1716-2025
- FDA 510(k) clearance · K183581The device's official FDA premarket clearance record
- FDA device classification · HBFOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.4305The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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