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.
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.
Ascom US, INC. is recalling 319 units of Mobile Monitoring Gateway and Unite Connect for Nurse Call due to a software malfunction that prevents automatic message forwarding if the primary module fails.
Siemens is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Baxter Healthcare is recalling 118 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.
Stryker is recalling four Mallinckrodt Evac Tracheal Tubes because the packaging may not be sealed, potentially compromising sterility.
Baxter Healthcare is recalling 288 units of GEM FlowCOUPLER devices because the instructions for use booklet may puncture the outer Tyvek lid.
Siemens is recalling Advia Chemistry Assay: LDL Cholesterol, Direct because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Sesderma is recalling 45 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Stryker is recalling two units of the Launcher Guiding Catheter because the device packaging may not be sealed.
Siemens Healthcare Diagnostics is recalling Syva Emit Methotrexate Assay units because they failed to meet the 20-hour on-board stability claim, potentially causing increased methotrexate values.
Sesderma is recalling 66 bottles of Repaskin 50 sunscreen due to cGMP deviations. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.
Sesderma is recalling 44 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Sesderma is recalling 20 bottles of Repaskin 30 sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.
Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Dr. Reddy's Laboratories is recalling 50,280 bottles of Ondansetron Tablets USP, 4 mg, due to failed impurities and degradation specifications.
Pilgrim's Pride is expanding a recall of fully cooked chicken products due to possible contamination with extraneous metal materials.
Iowa Select Herbs LLC is recalling 1-gallon bottles of Alcohol-Free Cyperus Leaf because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.
Iowa Select Herbs LLC is recalling 7.5 fl. oz. bottles of Cranberry because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.
Iowa Select Herbs LLC is recalling Momordica Leaf under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.
Iowa Select Herbs LLC is recalling Rhodiola Root products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.
Iowa Select Herbs LLC is recalling Hawthorn Berry dietary supplements because they are misbranded, unapproved new drugs, and adulterated.
Iowa Select Herbs LLC is recalling Yohimbe Bark products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.
Iowa Select Herbs LLC is recalling Propolis (Ligustrum lucidum) supplements because they are misbranded, unapproved new drugs, and adulterated dietary supplements.
Iowa Select Herbs LLC is recalling Jewel Weed under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.
Iowa Select Herbs LLC is recalling Milk Thistle Seed products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.