Recall record at a glance
| Official record | Z-0970-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Vortex Surgical Inc. |
| Report date | Feb 7, 2024 |
| Recall initiation date | Dec 18, 2023 |
| Quantity | 800 devices |
| Location | Saint Charles, MO, United States |
Official product description
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Why the product 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.
Distribution information
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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