The Recall Desk

FDA (Devices) recall action 96223

Aesculap Inc recalled 5 products on 2025-03-19

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-03-19
Critical
0
Units
1,079,883

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··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.

    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;
    Category
    Distribution
    1 state
  • HighFDA (Devices)··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.

    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,
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2025-03-19

    Hemostatic Forceps Recalled Due to Clamp Breakage in Surgical Use

    Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ52
    Category
    Distribution
    1 state