medical Class II Updated 2025-03-19

Aesculap Inc recalls Numerous models of nonsterile hemostatic forceps: (1) REF

Recalled 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 BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN numbers: (1) REF BJ500R - 04038653139378; (2) REF BJ501R - 04038653139385; (3) REF BJ511R - 04038653139392; (4) REF BJ520R - 04038653139408; (5) REF BJ521R - 04038653139415; (6) REF BJ522R - 04038653139422; (7) REF BJ524R - 04046963364250; (8) REF BJ527R - 04038653139446; (9) REF BJ530R - 04038653139453; (10) REF BJ531R - 04038653139460; (11) REF BJ532R - 04038653139477; (12) REF BJ534R - 04038653027798; (13) REF BJ550R - 04038653139484; (14) REF BJ551R - 04038653139491; (15) REF BJ552R - 04038653139507; (16) REF BJ553R - 04038653139514; (17) REF MD591 - 04046963365592; and (18) REF MD592 - 04046963365608.
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