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.
Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution due to CGMP deviations.
Baxter Healthcare is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.
ICU Medical is recalling specific blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Medtronic is recalling 47 CD HORIZON Spinal System screws because they are incorrectly laser marked as 5.5 mm diameter when they are actually 5.0 mm.
ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free that may contain small amounts of the chemical.
ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
ICU Medical is recalling specific blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The devices were distributed in the US and several international countries.
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Morton Grove Pharmaceuticals is recalling 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution because the tamper-evident foil seal is not completely intact.
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free because they may contain small amounts of DEHP.
ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.
Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.
ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.