Recall record at a glance
| Official record | Z-1312-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Aesculap Inc. |
| Report date | Mar 19, 2025 |
| Recall initiation date | Jan 31, 2025 |
| Quantity | 47,078 forceps |
| Location | Center Valley, PA, United States |
Official product description
Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.
Why the product was recalled
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Distribution information
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
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: Letter.
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
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