Recall of B. Braun Hemodialysis Bloodlines Due to Air Bubble Risk
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 4,848 units of its hemodialysis bloodlines because of potential air bubble accumulation, which could pose serious health risks.
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 and Canada. 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, cpsc, Devices.
Recall of B. Braun Hemodialysis Bloodlines
What Happened
B Braun Medical Inc has initiated a voluntary recall of certain hemodialysis bloodlines due to the potential for the accumulation of small air bubbles in the arterial line caused by 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 2.6MM PUMP SEGMENT, with Model Number: B3-3632M3705. A total of 4,848 units are involved, including all lots manufactured since 01AUG2025. The product has UDI-DI Primary: 04046955348824 and UDI-DI Unit: 04046955348817. Distribution occurred nationwide in the United States and in Canada.
What You Should Do
Consumers who have the affected products should contact B Braun Medical Inc for further instructions, as the recall was initiated via letter notification.
Why This Matters
This recall is classified as Class I by the FDA, indicating a reasonable probability of serious adverse health consequences, highlighting the importance of addressing potential risks in medical devices used in hemodialysis.
Source
FDA Recall Number: Z-1802-2026
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 (1,171 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.