3B Medical Rio II Nasal Pillows Interface Recall: Packaging Labeling Discrepancy
3B Medical recalls Rio II Nasal Pillows Interface models RII1001-1003 due to packaging and labeling errors that may cause incorrect size identification. Affected units include specific lot codes.
Lower-risk recall
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Contact the company
What happened, in plain English
3B Medical is recalling Rio II Nasal Pillows Interface devices with model numbers RII1001 (Small), RII1002 (Medium), and RII1003 (Large) because of a packaging and labeling discrepancy that could lead to incorrect size identification. This issue does not pose a safety risk but may cause confusion in selecting the right device for medical use. Read more at govinfonow.com/recall/57843-3b-medical-rio-ii-nasal-pillows-interface-recall-packaging-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/57843-3b-medical-rio-ii-nasal-pillows-interface-recall-packaging-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2740-2026
Cite this page
“3B Medical Rio II Nasal Pillows Interface Recall: Packaging Labeling Discrepancy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57843-3b-medical-rio-ii-nasal-pillows-interface-recall-packaging-labeling. Based on FDA recall #Z-2740-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2740-2026%22&limit=1).
Why it’s dangerous
The recall involves a packaging and labeling discrepancy that may cause incorrect identification of the device size. This could lead to patients using the wrong size nasal pillows interface, which might not fit properly with their PAP device. However, this does not pose a direct safety risk to the user.
Who’s affected
Patients using positive airway pressure therapy devices with the Rio II Nasal Pillows Interface are likely affected. Those who have the specific model numbers and lot codes listed in the recall are at risk of receiving the wrong size device.
How to tell if you have this one
Check for model numbers RII1001 (Small), RII1002 (Medium), or RII1003 (Large) on the packaging. Affected units include specific lot codes: 220121 and 220191 for each model.
- Brand
3B Medical- Category
Medical device
What to do — step by step
Check Device Model
Identify the model number on the packaging to see if it is RII1001, RII1002, or RII1003.
Verify Lot Code
Check the lot code on the packaging; affected units have lot codes 220121 or 220191.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to return the device?
The recall does not require returning the device; it is a labeling issue that may affect device selection.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2740-2026 (June 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2740-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.