CLASS II ONGOING Device recall · Reported 22 Jul 2026 · FDA Enforcement Report
Rio" II Nasal Pillows Interface recalled by 3B Medical
3B Medical is recalling Rio" II Nasal Pillows Interface, distributed nationwide in the US. The recall was initiated on 15 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2740-2026
- FDA event ID
- 99247
- Recalling firm
- 3B Medical, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jun 2023
- FDA classified
- 15 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Medical Software
Timeline
| 15 Jun 2023 | Recall initiated by company | |
| 15 Jul 2026 | Classified by FDA | +1126 days |
| 22 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Which lots are affected?
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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