Aesculap Inc: Medical Device Recall in 2025 - (Recall #: Z-1311-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 31, 2025

Date Posted: March 19, 2025

Recall Number: Z-1311-2025

Event ID: 96223

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,147 forceps

Code Information:

GTIN numbers: (1) REF FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) REF FB462R - 04038653156115; (5) REF FB469R - 04038653156184; (6) REF FB567R - 04038653156948; (7) REF FB568R - 04038653156955; (8) REF FB569R - 04038653156962; (9) REF FB729R - 04038653157617; (10) REF FB730R - 04038653157624; (11) REF FB736R - 04038653157686; (12) REF FB737R - 04038653157693; and (13) REF FB738R - 04038653157709.

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.

Voluntary or Mandated:

Voluntary: Firm initiated