The Recall Desk
HighFDA (Devices)·Z-1311-2025·Announced 2025-03-19

Multiple hemostatic forceps models recalled due to clamp breakage risk

Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.

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 no reported injuries, hospitalizations, or deaths. However, hemostatic forceps are risk-of-harm surgical instruments used in cardiovascular and pediatric procedures, where clamp breakage during use could result in serious intraoperative complications. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Aesculap Inc is recalling 1,147 hemostatic forceps across 13 models, including Glover, Leland-Jones, and Cooley variants. These nonsterile surgical instruments are used in cardiovascular and pediatric surgery.

The forceps can break at the clamp when used in ways not covered by the original design specifications. This poses a risk during surgical procedures when the instruments are used beyond their intended design scope.

The affected forceps were distributed nationwide, to Puerto Rico, Canada, Bermuda, Bahamas, Qatar, and government/military healthcare facilities. Specific product identifiers include reference numbers FB458R through FB738R with corresponding GTIN codes. Healthcare providers should stop using the recalled products and contact Aesculap for replacement or return instructions.

The recalled product

Product
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM;
Manufacturer
Aesculap Inc
Category
Medical Device — Surgical Instruments / Hemostatic Clamps
Hazard
  • equipment-failure
  • design-defect

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 (13)

  • GTIN numbers: (1) REF FB458R - 04038653156078
  • (2) REF FB459R - 04038653156085
  • (3) REF FB461R - 04038653156108
  • (4) REF FB462R - 04038653156115
  • (5) REF FB469R - 04038653156184
  • (6) REF FB567R - 04038653156948
  • (7) REF FB568R - 04038653156955
  • (8) REF FB569R - 04038653156962
  • (9) REF FB729R - 04038653157617
  • (10) REF FB730R - 04038653157624
  • (11) REF FB736R - 04038653157686
  • (12) REF FB737R - 04038653157693
  • and (13) REF FB738R - 04038653157709.

Distribution

Distributed nationwide across the United States.

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