Aesculap Inc: Device Recall
Recall #Z-1308-2025 · 01/31/2025
Recall Details
- Recall Number
- Z-1308-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Aesculap Inc
- Status
- Ongoing
- Date Initiated
- 01/31/2025
- Location
- Center Valley, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,979 forceps
Reason for Recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Product Description
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.
Distribution Pattern
Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.
Other Recalls by Aesculap Inc
- Class II: Risk 09/24/2025
- Class II: Risk 09/24/2025
- Class II: Risk 09/24/2025
- Class II: Risk 09/24/2025
- Class II: Risk 01/31/2025