FDA (Devices) recall action 93275
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.
Affected lots of product may experience technical distortions to a greater extent than expected.
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.
PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.
PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.
PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.
PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.