Medical device recalls Moderate risk

Numerous models of nonsterile hemostatic forceps: REF BH951R recalled over sterility concerns

Recall date
January 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Aesculap Inc recalls Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, N…
Recall number
Z-1312-2025
FDA classification
Class II
Brand / firm
Aesculap Inc
Sold / distributed
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

Why it was recalled

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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