Quick Facts at a Glance
- Recall Date
- June 15, 2023
- Hazard Level
- HIGH
- Brand
- 3B Medical
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- 3B Medical
- Model numbers
- Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 15, 2023
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact 3B Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Reason: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).. Classification: Class II. Quantity: 375. Distribution: US Nationwide distribution.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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