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.
Bacalafoods Corp is recalling Finola Style Octopus in Oil because the product contains squid but is labeled as octopus.
Beckman Coulter is recalling 43 PrepPlus systems because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.
Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.
G & W Laboratories is recalling Clobetasol Propionate Ointment 0.05% due to out-of-specification results for a known impurity.
American Pharmaceutical Ingredients LLC is recalling Methocarbamol USP due to lack of quality assurance at the API manufacturer.
Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
Sandoz Incorporated is recalling specific lots of Amitriptyline Hydrochloride 25 mg tablets because they were cross-contaminated with Imipramine.
Leica Microsystems is recalling 812 ASP6025 Tissue Processors because the voltage labels on the rear alarm connectors are incorrect.
Nutri-Dyn Midwest, Inc. is recalling 856 bottles of Calcium D-Glucarate Plus because they were mistakenly labeled as St. John's Wort during production.
Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Bacalafoods Corp is recalling Finola Style Octopus in Garlic because the product contains squid instead of octopus. The recall covers 340 boxes distributed in Puerto Rico.
Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.
GSK Consumer Healthcare is recalling 15,708 tubes of Parodontax Whitening toothpaste due to the possibility of metal in the product.
Sabor Mexicano is recalling Homemade Corn Chips because the label listed 15 mg of sodium instead of the correct 250 mg.
ProSupps USA LLC is recalling 28,045 units of Mr. Hyde Green Apple supplements because they contain the non-dietary ingredient Picamilon.
ProSupps USA LLC is recalling Mr. Hyde Watermelon supplements because they contain the non-dietary ingredient Picamilon.
ProSupps USA LLC is recalling 6,348 units of Dr. Jekyll V2 Watermelon domestic because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
ProSupps USA LLC is recalling Dr. Jekyll 30 Fruit Punch because it is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.
AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.
Beckman Coulter is recalling Access Total T3 immunoassays because they are susceptible to biotin interference, which may affect test results.
Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP active pharmaceutical ingredient due to misbranding. The product is subject to FDA Import Alert 66-66.
Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.