3B Medical Recalls Rio II Nasal Pillows Interface
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
3B Medical, Inc. is recalling 375 units of Rio II Nasal Pillows Interface due to packaging and labeling discrepancies involving product size and UDI.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 2026 and geographically references United States. Its severity classification of "medium" 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, medical-devices.
What Happened
3B Medical, Inc. initiated a voluntary recall due to a packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Which Products Are Affected
The recall affects the Rio II Nasal Pillows Interface, model/catalog numbers RII1001 (Small), RII1002 (Medium), and RII1003 (Large). Affected lots include 220121 and 220191 for all three catalog numbers. A total of 375 units are involved in US Nationwide distribution.
What You Should Do
Consumers should refer to the recalling firm for further information regarding the affected products.
Why This Matters
The Class II recall addresses a labeling issue that could lead to incorrect product size identification during use with positive airway pressure therapy devices.
Source
FDA Recall Z-2740-2026 - Event ID 99247, initiated June 15, 2023.
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 (905 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.