The Recall Desk
HighFDA (Devices)·Z-1310-2025·Announced 2025-03-19

Multiple Aesculap Surgical Forceps Models Recalled for Clamp Breakage

Aesculap Inc is recalling 93,714 hemostatic forceps across 83 models due to clamp breakage that occurs when forceps are used in ways not covered by the design.

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 FDA Class II recall involves a structural failure of surgical instruments where the clamps can break during use. While no patient injuries have been reported, the hazard poses a risk of harm in surgical applications, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Aesculap Inc is recalling 93,714 hemostatic forceps across 83 different reference models. These are surgical instruments including Fuchsig Artery Forceps, Pean Artery Forceps, Overholt Forceps, Zenker Suture Forceps, and numerous other models designed for hemostasis and suture handling.

The recall was issued because the forceps have been used in ways not covered by the design, resulting in breakage of the clamps.

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

Healthcare facilities that have received these forceps should stop use and contact Aesculap Inc or the FDA for guidance on the recall.

The recalled product

Product
Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Ove
Manufacturer
Aesculap Inc
Category
Medical Device — Hemostatic Forceps
Hazard
Affected units
93,714

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) REF BH198R - 04038653026029
  • (2) REF BH304R - 04038653026333
  • (3) REF BH813R - 04038653026968
  • (4) REF BJ016R - 04038653027163
  • (5) REF BJ020R - 04038653027200
  • (6) REF BJ021R - 04038653027217
  • (7) REF BJ022R - 04038653027224
  • (8) REF BJ023R - 04038653027231
  • (9) REF BJ025R - 04038653027255
  • (10) REF BJ026R - 04038653027262
  • (11) REF BJ031R - 04038653027279
  • (12) REF BJ034R - 04038653027309
  • (13) REF BJ035R - 04038653027316
  • (14) REF BJ037R - 04046963458201
  • (15) REF BJ038R - 04046963458218
  • (16) REF BJ039R - 04046963458225
  • (17) REF BJ041R - 04038653027323
  • (18) REF BJ042R - 04038653027330
  • (19) REF BJ043R - 04038653027347
  • (20) REF BJ044R - 04038653027354

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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