Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF… recallZ-0970-2024 · Vortex Surgical Inc. · initiated Dec 18, 2023
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vortex Surgical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0970-2024
- Status
- Terminated
- Initiated by the company
- Dec 18, 2023
- Posted by the FDA
- Feb 1, 2024
- Recalling firm
- Vortex Surgical Inc.
- Quantity
- 800 devices
- Product code
- HNR
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Product description
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Code information (models, lots, serial numbers)
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vortex Surgical Inc VS0740.25Vortex Surgical, Inc. · Forceps, Ophthalmic2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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