The Recall Desk
HighFDA (Devices)·Z-1312-2025·Announced 2025-03-19

Aesculap hemostatic forceps recalled due to clamp breakage

Aesculap is recalling 47,078 surgical forceps designed to control bleeding. The devices' clamps break when used outside design parameters, potentially compromising their effectiveness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a structural defect (clamp breakage) in surgical hemostatic forceps. The defect represents a potential risk of harm, as failure of these instruments could compromise their intended function. However, no injuries, illnesses, or hospitalizations have been reported. Per the severity rubric, risk-of-harm products without reported injury are scored at 3 (High).

Plain-English summary

Aesculap Inc. is recalling seven models of nonsterile hemostatic forceps: Negus Tonsil Forceps (REF BH951R and BH952R), Schmidt Tonsil Forceps (REF BH957R, BH959R, BH961R, and BH963R), and Wilson Tonsil Forceps (REF BH965R). In total, 47,078 forceps are affected by this recall.

The recall was initiated due to clamp breakage when the forceps are used in ways not covered by the design specification. This defect may compromise the instruments' intended function.

The recalled forceps were distributed nationwide, to Puerto Rico, and to military and government facilities. International distribution included Canada, Bermuda, the Bahamas, and Qatar.

Healthcare facilities and individuals possessing the recalled forceps should refer to FDA recall number Z-1312-2025 for further information and recall procedures.

The recalled product

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,
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical Instruments
Hazard
  • clamp-breakage
  • device-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

Distributed nationwide across the United States.

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