# FDA recall D-0498-2026

> **B BRAUN MEDICAL INC** · Class II · drug recall initiated 2026-04-02.

## Product

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

## Reason for recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0498-2026
- **Recalling firm:** B BRAUN MEDICAL INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-02
- **Report date:** 2026-04-29

- **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-0498-2026

## Citation

> AI Analytics. FDA recall D-0498-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0498-2026. Source: US FDA. Licensed CC0.

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