FDA (Devices) recall action 69422
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
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.
MedX Holdings is recalling four cervical extension machines because required safety re-testing was not completed during manufacturing.
MedX Holdings is recalling nine Lumbar Extension Machines because required safety re-testing was not completed during manufacturing.