Numerous models of nonsterile hemostatic forceps: — Class II medical device recall Z-1311-2025
Ongoing recall by Aesculap Inc, reported 2025-03-19, distributed nationwide. The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
| Recall number | Z-1311-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Inc, Center Valley, PA, United States |
| Recall initiated | 2025-01-31 |
| Classified | 2025-03-11 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, BS, CA, QA |
| Quantity | 1,147 forceps |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04038653156078, 04038653156085, 04038653156108, 04038653156115, 04038653156184, 04038653156948, 04038653156955, 04038653156962, 04038653157617, 04038653157624, 04038653157686, 04038653157693, 04038653157709 |
| Model numbers | 04038653156078, 04038653156085, 04038653156108, 04038653156115, 04038653156184, 04038653156948, 04038653156955, 04038653156962, 04038653157617, 04038653157624, 04038653157686, 04038653157693, 04038653157709, FB458R, FB459R, FB461R, FB462R, FB469R, FB567R, FB568R, FB569R, FB729R, FB730R, FB736R, FB737R and 1 more |
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 for recall
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1311-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.