FDA Device recall Z-2740-2026
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)…
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)… by 3b Medical, citing packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2740-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-15 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | 3b Medical |
| Distribution | US |
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
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Identifiers
| code_info | Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 22…Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2740-2026%22
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