FDA Issues Recall for B Braun Hemodialysis Bloodlines
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
B Braun Medical Inc. is recalling 4,884 units of its Hemodialysis Bloodlines due to potential air bubble accumulation in the arterial line.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 4, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
B Braun Medical Inc. is recalling its Hemodialysis Bloodlines because of the potential for small air bubbles to accumulate in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Which Products Are Affected
The affected product is B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT, with Model Number: B3-4630M4705. A total of 4,884 units are involved, including all lots manufactured since 05AUG2025. The UDI-DI Primary is 04046955348848 and UDI-DI Unit is 04046955348831. Distribution was nationwide in the United States and also to Canada.
What You Should Do
Consumers should follow the instructions in the letter from B Braun Medical Inc., as this is a firm-initiated voluntary recall.
Why This Matters
This recall affects medical devices used in hemodialysis, potentially posing a serious risk if air bubbles accumulate, and involves thousands of units distributed across the U.S. and Canada.
Source
According to the FDA recall notice, recall number Z-1803-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,057 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 4, 2026.
Frequently Asked Questions
Common questions about this FDA recall.