FDA Medical devices recall ·
Numerous models of nonsterile hemostatic forceps: (1) recall
- Recall number
- Z-1312-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- Aesculap Inc
3773 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 47,078 forceps
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN numbers: (1) REF BH951R - 04038653027026; (2) REF BH952R - 04038653139200; (3) REF BH957R - 04038653027033; (4) REF BH959R - 04038653027040; (5) REF BH961R - 04038653027057; (6) REF BH963R - 04038653027064; and (7) REF BH965R - 04038653027071.
Distribution
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1312-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.