FDA Medical Device Recalls (openFDA)
Conmed Corporation: ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4305. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
- Recall number
- Z-0086-2007
- Recalling firm
- Conmed Corporation
- Product
- ConMed DetachaTip Laparoscopic Instrument: Babcock Multiple Use Grasper, 5mm x 43cm length, REF/Product Code 1-4305. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.
- Status
- Terminated
- Initiated
- 2006-10-12
- Posted
- 2006-10-27
- Terminated
- 2012-08-30
- Reason
- The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Root cause
- Nonconforming Material/Component
- Action
- On 10/12/06, ConMed sent "URGENT DEVICE RECALL" packages (letter dated 10/11/06) to the domestic accounts via UPS Ground, and via UPS Express for the International accounts. Devices are to be removed from use and returned.
- Quantity
- 60 units
- Distribution
- Worldwide
- Lot, serial or model codes
- REF/Product Code 1-4305, all lot codes manufactured between 08/25/2003 and 03/24/2005. [Lot codes on unopened boxes and packaging contain a lot code in the following form: for example 0409271 - 04 represents the year 2004, 09 represents the month of the year, 27 represents the day of the month, and the last digit 1 represents the manufacturing shift code. Lot codes are located on the device in this form: for example 40927 - 4 represents the year 2004, 09 represents the month of the year, and 27 represents the day of the month.]
- 510(k) numbers
- ["K924283"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- 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