FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
- Recall number
- Z-0431-06
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
- Status
- Terminated
- Initiated
- 2005-11-28
- Posted
- 2006-01-24
- Terminated
- 2007-02-26
- Reason
- Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
- Root cause
- Other
- Action
- Customers were notified of the recall on 11/28/2005 via letter sent by UPS.
- Quantity
- 536 units
- Distribution
- The device is distributed nationwide to hospitals nationwide.
- Lot, serial or model codes
- Lot 050678 and Lot 050575.
- 510(k) numbers
- ["K021989"]
- PMA numbers
- not on file
- Product code
- LFL
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- 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