FDA (Devices) recall action 98140
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Potential for fraying on the body support strap.
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.
Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.
Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.
Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.