Aesculap Inc: Device Recall
Recall #Z-1311-2025 · 01/31/2025
Recall Details
- Recall Number
- Z-1311-2025
- 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
- 1,147 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 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; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.
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