FDA (Devices) recall action 66191
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.
Failure to submit a premarket submission and gain approval of a medical device.
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.
Pinook-Usa is recalling 28,994 Pinook Mini Massagers because the company failed to submit a premarket submission and gain approval for the medical device.
Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.