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.
Health One Pharmaceuticals is recalling Protein Mix dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Stryker Orthobiologics is recalling Vitagel surgical hemostat shipments that were not delivered within validated timeframes, potentially compromising the product's required cold storage.
Health One Pharmaceuticals is recalling 764 units of Pure Trans-Reveratol dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling 817 units of Berberine dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Saw Palmetto Plus, 60 capsules, due to significant violations of cGMP regulations for dietary supplements.
Health One Pharmaceuticals is recalling Pretty Slim dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Herbal Health dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Omega-3 dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Lucid-Head dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
C.R. Bard is recalling specific lots of urinary drainage bags due to a potential breach of the sterile barrier packaging.
Biologic Therapies, Inc. is recalling 2,797 Bio-MAC Cannula (Needle) Sets because the devices were distributed without proper FDA clearance.
Microtek Medical is recalling sterile smoke evacuator wands because the packaging contains latex but lacks the required warning label.
Health One Pharmaceuticals is recalling Innoslim dietary supplements due to significant violations of cGMP regulations.
ProSupps USA LLC is recalling MR. Hyde Intense Energy Pre Workout because it contains more yohimbine HCL than declared on the label.
Health One Pharmaceuticals is recalling Pearl Shen dietary supplements due to significant violations of cGMP regulations.
Synthes, Inc. is recalling 131 Aiming Arms from the TFN-ADVANCED system because the guide sleeve may jam, potentially delaying instrument removal.
Health One Pharmaceuticals is recalling Reishi Spore Gen dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Microtek Medical Inc is recalling 11 units of Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.
Health One Pharmaceuticals is recalling Dong Cong xia Cao dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling 48,400 units of Korean Ginseng dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Vege Slim 4 U dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Gymostemma Capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
Nidek Inc is recalling 799 YC-1800 Ophthalmic YAG Laser Systems due to complaints of pitting lenses that may cause unclear images.
Health One Pharmaceuticals is recalling Red Ganoderma dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling 1,015 units of Cordyceps, 60 Capsules due to significant violations of current Good Manufacturing Practice (cGMP) regulations.