Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface… — Class II medical device recall Z-2740-2026
Ongoing recall by 3B Medical, Inc., reported 2026-07-22, distributed nationwide. Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifi
| Recall number | Z-2740-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3B Medical, Inc., Dublin, OH, United States |
| Recall initiated | 2023-06-15 |
| Classified | 2026-07-15 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 375 |
| Reason classes | labeling |
| Lot numbers | 220121, 220191, RII1001, RII1002, RII1003 |
| Model numbers | RII1001, RII1002, RII1003 |
Product
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 for recall
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2740-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.