The Recall Desk
HighFDA (Devices)·Z-1309-2025·Announced 2025-03-19

Aesculap Hemostatic Forceps Recalled Due to Clamp Breakage

Aesculap Inc is recalling 917,965 units of nonsterile hemostatic forceps across multiple models because the clamps can break when used beyond design specifications. No injuries have been reported.

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: FDA Class II medical device with structural defect potential (clamp breakage under certain use conditions). No illnesses or injuries reported. Per rubric, Class II recalls without reported injuries are limited to score 3 maximum.

Plain-English summary

Aesculap Inc is recalling 917,965 units of nonsterile hemostatic forceps across multiple models, including the Carrel Artery, Hartmann Mosquito, Micro-Halsted, Kelly, Crile, Kocher, Leriche Delicate, and Spencer-Wells models, among others used in surgical procedures for hemostasis.

The forceps are being recalled because the clamps can break when the instruments are used in ways not covered by the design specifications. No injuries or illnesses have been reported.

The recalled forceps were distributed nationwide, including Puerto Rico, as well as to government and military facilities. International distribution was made to Canada, Bermuda, Bahamas, and Qatar. Healthcare providers should verify their inventory against the complete list of recalled model reference numbers and remove any forceps showing signs of structural compromise from service.

The recalled product

Product
Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Hals
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical / Hemostatic Forceps
Hazard
Affected units
917,965

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 (20)

  • GTIN numbers: (1) BH100R - 04038653139064
  • (2) BH104R - 04038653025558
  • (3)BH105R - 04038653025565
  • (4) BH108R - 04038653025572
  • (5) BH109R - 04038653025589
  • (6) BH114R - 04038653025619
  • (7) BH115R - 04038653025626
  • (8) BH118R - 04038653025633
  • (9) BH119R - 04038653025640
  • (10) BH120R - 04038653025657
  • (11) BH121R - 04038653025664
  • (12) BH130R - 04038653025725
  • (13) BH131R - 04038653025732
  • (14) BH134R - 04038653025749
  • (15) BH135R - 04038653025756
  • (16) BH139R - 04038653025763
  • (17) BH140R - 04038653025770
  • (18) BH141R - 04038653025787
  • (19) BH143R - 04038653139088
  • (20) BH144R - 04038653025794

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Aesculap Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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Same hazard · clamp breakage

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