Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.
Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.
Viatris Inc is recalling 35,883 bottles of Levothyroxine Sodium Tablets (112 mcg) distributed nationwide due to potency failures. Some tablets contain too much active ingredient (superpotent) and others too little (subpotent). No illnesses have been reported.
Giant Eagle churned Butter Pecan Reduced Fat ice cream is being recalled because it contains undeclared soy (soy lecithin), posing a risk to consumers with soy allergies.
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.
FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may lodge in the bottle nozzle, preventing patients from dispensing the medication.
DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.
Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.
An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.
Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.
Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.
Viatris Inc is recalling Levothyroxine Sodium Tablets USP 150 mcg nationwide due to potency failures. Affected lots containing both subpotent and superpotent tablets expire June 2025.
Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.
Fresh Gourmet tortilla strips are recalled due to undeclared wheat found in crispy onion pieces mixed into the product. Consumers with wheat allergies are at risk.
Sweet Sam's Baking Company is recalling 10,164 units of Individually Wrapped Chocolate Chunk Brownies due to undeclared soy lecithin, a major allergen. Consumers with soy allergies face a potential health risk from this labeling oversight.
Hungryroot Ricotta Stuffed Shells are being recalled due to potential contamination with Listeria monocytogenes. Affected products have been distributed in multiple states.
Piazza Produce is recalling 289 units of CIBUS Fresh Autumn Turkey Sandwiches due to possible Listeria monocytogenes contamination in the spreadable brie ingredient. Products were distributed in six states with expiration dates from November 1-9, 2024.
Noah Medical is recalling Galaxy bronchoscope units due to risk that biopsy tools may require excessive force or fail to pass through the scope channel when the bronchoscope is sharply bent, potentially causing tissue injury or pneumothorax.
Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.
Micro-X Ltd. is recalling 18 MICRO-X Rover Mobile X-ray Systems because they can deliver lower radiation doses than operators set. The affected units use Control Board PCBA 12425-03 or earlier.
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
Viatris Inc is recalling Levothyroxine Sodium Tablets USP 75 mcg due to potency failures affecting approximately 63,077 bottles distributed nationwide in the US and Puerto Rico. Some tablets are superpotent while others are subpotent.
Joseph Epstein Food Enterprises recalls Mama Mancini's Stuffed Shells with Sauce and Mozzarella Cheese due to potential Listeria monocytogenes contamination. Affected products were distributed to six states.
Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.
Viatris Inc is recalling Levothyroxine Sodium 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.