FDA Device recall Z-1311-2025
Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM
- FDA Device
- Class II
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class II recall of Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM by Aesculap, citing the forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1311-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aesculap |
| Distribution | US |
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.
Identifiers
| code_info | GTIN numbers: (1) REF FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) R…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2025%22
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