Numerous models of nonsterile hemostatic forceps: — Class II medical device recall Z-1308-2025
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-1308-2025 |
|---|---|
| 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 | 19,979 forceps |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04038653027798, 04038653139378, 04038653139385, 04038653139392, 04038653139408, 04038653139415, 04038653139422, 04038653139446, 04038653139453, 04038653139460, 04038653139477, 04038653139484, 04038653139491, 04038653139507, 04038653139514, 04046963364250, 04046963365592, 04046963365608 |
| Model numbers | 04038653027798, 04038653139378, 04038653139385, 04038653139392, 04038653139408, 04038653139415, 04038653139422, 04038653139446, 04038653139453, 04038653139460, 04038653139477, 04038653139484, 04038653139491, 04038653139507, 04038653139514, 04046963364250, 04046963365592, 04046963365608, BJ500R, BJ501R, BJ511R, BJ520R, BJ521R, BJ522R, BJ524R and 11 more |
Product
Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.
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-1308-2025. 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.