Recall of B. Braun Hemodialysis Bloodlines Due to Potential 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 1,174,271 units of its Hemodialysis Bloodlines because of a potential for air bubbles in the arterial line, affecting products distributed nationwide in the US and Canada.
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 has initiated a recall due to the potential for the accumulation of small air bubbles in the arterial line of the hemodialysis bloodlines, caused by adherence of blood gases to the tubing under negative pressure.
Which Products Are Affected
The affected product is B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA, with Model Number: SL-2000M2095DA. A total of 1,174,271 units are involved, including all lots manufactured since 09JUN2025. The product has UDI-DI Primary: 04046955776023 and UDI-DI Unit: 04046955776016. Distribution occurred nationwide in the United States and in Canada.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, for instructions on how to proceed with the recall initiated by B Braun Medical Inc.
Why This Matters
This recall involves over a million units of a medical device used in hemodialysis, highlighting potential risks in patient treatment due to the air bubble issue.
Source
From FDA recall notice for event ID 98552 and recall number Z-1800-2026.
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 (1,105 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.