FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. (NeuroSciences): Extended Tip Applicator, 8CM, Box of 5.
- Recall number
- Z-1958-2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- Extended Tip Applicator, 8CM, Box of 5.
- Status
- Open, Classified
- Initiated
- 2025-05-22
- Posted
- 2025-06-20
- Terminated
- not on file
- Reason
- Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- Root cause
- Process change control
- Action
- An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales Representatives and Distributors are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at FCA2@integralife.com or by FAX at 1-609-750-4220. Distributors who further distributed affected devices are to forward the provided notification to their customers and collect Acknowledgement forms on their behalf to submit to Integra. Sales Representatives will be contacted by Post Market Quality to coordinate return of devices. Consignees with any questions are to contact Customer Service by phone at 1-800-654-2873 or by email at custsvcnj@integralife.com. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.
- Quantity
- 6,216 units
- Distribution
- Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
- Lot, serial or model codes
- Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.
- 510(k) numbers
- ["K091315"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28