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.
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
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.
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.
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.
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.
Identify the model number on the packaging to see if it is RII1001, RII1002, or RII1003.
Check the lot code on the packaging; affected units have lot codes 220121 or 220191.
No, this recall is for a labeling discrepancy that may cause incorrect size identification but does not pose a safety risk.
Check the model number and lot code on the packaging. If it matches the affected models and lot codes, contact 3B Medical for guidance.
The recall does not require returning the device; it is a labeling issue that may affect device selection.
We’ve drafted a message you can send 3B Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2740-2026 — 3B Medical 3B Medical Hello, I own a 3B Medical that is covered by recall Z-2740-2026 from 3B Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
