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Recall Observatory FDA recall evidence

Device 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.

Z-1312-2025

January 31, 2025

Class II

Product summary

Firm
Aesculap Inc
Event
Event 96223
Status
Ongoing
Classification
Class II
Quantity
47,078 forceps
Official record key
device-enforcement:Z-1312-2025

Official wording

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

Code information: 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 pattern: Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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