3B Medical, Inc.
3B Medical, Inc. has 3 FDA enforcement events on this register (3 product records) between 2023 and 2026: 3 device; the busiest year was 2023 with 1.
0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in OH and FL.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 4 Feb 2026 | React Health PHOENIX 5L Oxygen Concentrator | Device | Class II | 1 | Ongoing |
| 27 Nov 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators | Device | Class II | 1 | Ongoing |
| 15 Jun 2023 | 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… | Device | Class II | 1 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has 3B Medical, Inc. had?
3 enforcement events (3 product records) on this register, 2023–2026: 3 device.
Are any 3B Medical, Inc. recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are 3B Medical, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.