Recall Z-1311-2025— Aesculap Inc

Class II FDA medical device recall by Aesculap Inc, initiated 2025-01-31. FDA's recall record names no specific 510(k) clearance for this event. 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; (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.. Reason: The forceps have been used in ways not covered by the design resulting in breakage of the clamps..

Recalling firm

Aesculap Inc

Classification

Class II

Status

Ongoing

Initiated

2025-01-31

Firm location

Center Valley, PA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.