Recall Z-1312-2025— Aesculap Inc
Class II · Ongoing
Class II FDA medical device recall by Aesculap Inc, initiated 2025-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps..
- Recalling firm
- Aesculap Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-31
- Firm location
- Center Valley, PA, United States
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.
Reason for recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.