# FDA recall Z-1309-2025

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

## Product

Numerous models of nonsterile hemostatic forceps:  (1) REF BH100R, Carrel Artery Forceps 85MM;  (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;  (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;  (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM;  (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm;  (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM;  (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM;  (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM;  (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM;  (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM;  (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM;  (12) REF BH130R, Providence-Hosp FCPS Del STR140MM;  (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM;  (14) REF BH134R, Kelly Forceps Del STR 140MM;  (15) REF BH135R, Kelly Forceps Del CVM 140MM;  (16) REF BH139R, Dandy Delicate Forceps CVD140MM;  (17) REF BH140R, Baby Crile Forceps Del STR 140MM;  (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM;  (19) REF B

## 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-1309-2025
- **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-1309-2025

## Citation

> AI Analytics. FDA recall Z-1309-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1309-2025. Source: US FDA. Licensed CC0.

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