Food, drugs, devices › 3B Medical, Inc.
Device recall: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium
3B Medical, Inc. (Dublin, OH) initiated this device recall on 15 Jun 2023; FDA lists 1 product record under event 99247, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. 3B Medical, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
3B Medical, Inc., Dublin, OH.
Reason for recall
"Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN)."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2740-2026 | 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… | 375 | Class II | Ongoing | 22 Jul 2026 |
Context
Other enforcement events for 3B Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Feb 2026 | React Health PHOENIX 5L Oxygen Concentrator | Device | Class II | 1 |
| 27 Nov 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: | Device | Class II | 1 |
All 3 events for 3B Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.