Vortex Surgical ACTU8 FORCEPS recall
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Why was Vortex Surgical ACTU8 FORCEPS 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
- Product
- Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
- Recalling firm
- Vortex Surgical Inc.
- Quantity
- 800 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)