Critical Alert
B Braun Medical Inc Recalls B Braun Hemodialysis Bloodlines
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-1803-2026Medical Device
B Braun Medical Inc Recalls B Braun Hemodialysis Bloodlines
B Braun Medical Inc · Class I — Most Serious
Product Description
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Reason for Recall
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by B Braun Medical Inc on March 19, 2026. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. This recall affects 4,884 units and was distributed internationally, including the United States. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.