Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Get Tested International AB is recalling 12 units of its Peptic Ulcer Test (H. pylori) because the product was distributed without premarket approval or clearance.
Philips North America is recalling 6 CT 5300 systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.
Get Tested International AB is recalling 1210 units of its 3 in 1 STI Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 55 units of its SIBO 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.
Get Tested International AB is recalling 258 units of its HPV Antigen 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.
Blossom Pharmaceuticals is recalling 2400 containers of Wecare Calasoothe over current good manufacturing practice deviations.
Get Tested International AB is recalling 4 units of its MPOX Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 12 units of its Serotonin Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 463 units of its Gonorrhea test because the product was distributed without premarket approval or clearance.
Microbiologics is recalling 5 KWIK-STIK quality control kits because some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Get Tested International AB is recalling 128 units of its Ovulation Test (5 tests) because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 35 units of its Fecal Occult Blood 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 33 units of its Sperm Test because the product was distributed without premarket approval or clearance.
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 15 units of its Lactose Intolerance Test because the product was distributed without premarket approval or clearance.
Blossom Pharmaceuticals is recalling 1,560 containers of Dynashield Skin Protectant, 16 oz, over current good manufacturing practice deviations.
Philips North America is recalling 2,341 Incisive CT systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.
Get Tested International AB is recalling 4081 units of its Epstein-Barr Virus (EBV VCA & EBNA IgG) Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 528 units of its Syphilis Test because the product was distributed without premarket approval or clearance.
Get Tested International AB is recalling 3 units of its Biological Age & Longevity 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.
Get Tested International AB is recalling 76 units of its Allergy test Small because the product was distributed without premarket approval or clearance.