FDA Medical Device Recalls (openFDA)
Vortex Surgical Inc.: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
- Recall number
- Z-0970-2024
- Recalling firm
- Vortex Surgical Inc.
- Product
- Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
- Status
- Terminated
- Initiated
- 2023-12-18
- Posted
- 2024-02-01
- Terminated
- 2024-04-04
- Reason
- Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
- Root cause
- Device Design
- Action
- The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/18/2023 via email. The notice explained the problem with the device, risk to health associated with its use, and requested the return of all devices.
- Quantity
- 800 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
- Lot, serial or model codes
- UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNR
- Firm FEI
- 3013002167
- Firm city
- Saint Charles
- Firm state
- MO
- 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