# FDA recall D-0652-2025

> **B BRAUN MEDICAL INC** · Class II · drug recall initiated 2025-08-26.

## Product

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

## Reason for recall

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0652-2025
- **Recalling firm:** B BRAUN MEDICAL INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-26
- **Report date:** 2025-09-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2025

## Citation

> AI Analytics. FDA recall D-0652-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0652-2025. Source: US FDA. Licensed CC0.

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