FDA Medical Device Recalls (openFDA)
Silex Medical, LLC: Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
- Recall number
- Z-1900-2025
- Recalling firm
- Silex Medical, LLC
- Product
- Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
- Status
- Open, Classified
- Initiated
- 2024-01-09
- Posted
- 2025-06-02
- Terminated
- not on file
- Reason
- Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Root cause
- Process control
- Action
- Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
- Lot, serial or model codes
- Model/REF Number: 5881033. UDI-DI: B33158810330. Lot Number: M28188. Serial Numbers: 0107, 0108.
- 510(k) numbers
- ["K914910"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3005110411
- Firm city
- Southington
- Firm state
- CT
- 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