# FDA recall Z-1308-2025

> **Aesculap Inc** · Class II · device recall initiated 2025-01-31.

## 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, 

## Reason for recall

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

## Distribution

Distribution was made nationwide and to PR.  There was also government/military distribution.    Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

## Key facts

- **Recall number:** Z-1308-2025
- **Recalling firm:** Aesculap Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-31
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2025

## Citation

> AI Analytics. FDA recall Z-1308-2025. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1308-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*