FDA (Devices) recall action 95576
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Potential failure of affected units to recharge the battery of the oxygen concentrators.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.
CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.