FDA (Devices) recall action 70445
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.
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
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.
Biologic Therapies, Inc. is recalling 58 Bio-PLASTY Cannulas because they were distributed without proper FDA clearance and classification.
Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.
Biologic Therapies, Inc. is recalling 2,797 Bio-MAC Cannula (Needle) Sets because the devices were distributed without proper FDA clearance.