FDA (Devices) recall action 97896
The FDA (Devices) publishes a recall like this one as 92 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 92 pages.
Distribution without premarket approval/clearance.
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.
Get Tested International AB is recalling 2 units of its Pregnancy Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 166 units of its Candida Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling a product identified only by EAN 7340221701083 and SKU A-DR12, because it was distributed without premarket approval or clearance.
Breckenridge Pharmaceutical is recalling 3,397 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.
Get Tested International AB is recalling 3 units of its Food Allergy Panel Test (IgE) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 658 units of its Parasite Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 184 units of its Menopause (FSH) 2 Tests because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its Environmental Pollutants Profile Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 80 units of its Cholesterol Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its Food Sensitivity Test Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 1 unit of its GI Microbiome Profile Small because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 19 units of its Hair Mineral Analysis because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 36 units of its NAD Profile Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 940 units of its Lyme Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 31 units of its Leaky Gut Test because the product was distributed without premarket approval or clearance.
Medtronic is recalling 6,591 Aurora EV-ICD and Clinical EV-ICD single chamber extravascular defibrillators over the potential for delayed time to high-voltage therapy in a rare sequence of events.
Get Tested International AB is recalling 8 units of its IBS Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its Food Sensitivity Test Large because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 10 units of its Men's Hormone Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 17 units of its Adrenal Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 13 units of its Iodine Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 47 units of its Blood Type Test because the product was distributed without premarket approval or clearance.
Blossom Pharmaceuticals is recalling 18,912 containers of Wecare Enema, 4.5 Fl Oz, over current good manufacturing practice deviations.
Philips North America is recalling the IntelliVue Patient Monitor MX100 over a potential issue where the monitors did not alarm.
Get Tested International AB is recalling 4 units of its MPOX Test because the product was distributed without premarket approval or clearance.