3B Medical
3 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for 3B Medical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-22FDA-DeviceClass II3B Medical Rio II nasal pillows recalled for labeling discrepancy
3B Medical is recalling Rio II nasal pillows interfaces due to a packaging and labeling discrepancy affecting product size identification and device identifiers. The affected units have incorrect or mismatched labeling on certain lots, which could lead to patients receiving the wrong size for their CPAP or PAP therapy device.
- 2026-04-22FDA-DeviceClass IICheck your React Health PHOENIX 5L concentrator
3B Medical distributed 2 units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet the company's internal quality standards. The devices were distributed in New York. No injuries have been reported.
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