FDA (Drugs) recall action 97477

B BRAUN MEDICAL INC recalled 2 products on 2025-09-24

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products: 2
Announced: 2025-09-24
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

HighFDA (Drugs)··2025-09-24
Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage
B. Braun 0.9% Sodium Chloride Irrigation USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 16,228 bags are affected.
Product
SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
Category
Distribution
0 states
HighFDA (Drugs)··2025-09-24
Sterile water for injection recalled over port misalignment allowing fluid leakage
B. Braun Sterile Water for Injection USP, 3000 mL bags, is recalled for lack of assurance of sterility because port misalignment may allow fluid leakage. 26,316 bags are affected.
Product
STERILE WATER (WATER)
Category
Distribution
0 states

Why these products were recalled

1–2 of 2

Sodium chloride irrigation bags recalled over port misalignment allowing fluid leakage

Sterile water for injection recalled over port misalignment allowing fluid leakage