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.
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
THREE RIVERS brand Tutti-Frutti candy contains undeclared FD&C Yellow 5 and Yellow 6 dyes that were not listed on the label. Consumers allergic or sensitive to these colorants should not consume the product.
Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.
RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.
Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.
Augustine Surgical Inc. is recalling HotDog Return Electrode connector cables (Model A138) that display a 'Check Neutral Electrode Contact' error message. The recall affects 7 units distributed to Alabama, Texas, and Nevada.
DeRoyal Industries is recalling AMG Suction Connector Tubing because the connection between the tubing and suction device may not seal properly, potentially affecting patient care.
Super73 is recalling about 1,400 Model Year 2024 Z Miami SE and Z Adventure Core e-bikes sold April-September 2024. A retaining pin in the disc brake calipers can dislodge, causing brake failure and crash/injury hazards.
About 900 SEJOV five-drawer dressers sold on Amazon from September 2023 through August 2024 are unstable if not properly anchored to a wall, posing tip-over and entrapment hazards to children. No injuries have been reported.
Nazzaro Enterprises is recalling bowling pin sipper cups sold at bowling alleys nationwide because the red tape contains excessive lead. The company is offering refunds.
OdorStop Boot and Shoe Dryers and Deodorizers may pose a fire hazard due to electrical short circuits in the on-off switch. About 13,000 units have been recalled; no injuries have been reported.
Kubota is recalling approximately 2,600 MX5400DTC utility tractors due to clutch cable failure that can reduce braking power, creating a crash hazard. No injuries have been reported to date.
DR Power is recalling about 890 tow behind field and brush mowers because the blade carrier spindle bolt can loosen, causing the blade assembly to detach and pose a laceration hazard. No injuries reported.
Sauder is recalling about 15,800 tip-over restraint straps used on dressers and 4-drawer chests manufactured from July 2020 to August 2023. The straps can fail to prevent tip-over and entrapment hazards to children.
Homebox Blackout Roller Window Shades sold on Amazon from December 2022 to September 2024 feature long operating cords that pose strangulation and entanglement hazards to children. Consumers should place cords up and away from children.
Fjorden iPhone Camera Grips can release their coin batteries if dropped, creating an ingestion hazard for children. Swallowed coin batteries can cause serious internal injuries, chemical burns, and death.
About 690 Triumph TF250-X motorcycles are recalled due to plastic switch cubes that crack when exposed to brake fluid, creating electrical short circuits that can cause the motorcycle to start unexpectedly. No injuries have been reported.
Holosun has recalled approximately 9,400 firearm dot sights with accessible lithium coin batteries that pose an ingestion hazard. The products violate federal safety regulations by lacking child-resistant packaging and required warning labels.
Shadeks recalls ShadesU Roller Window Shades due to long operating cords that pose strangulation and entanglement hazards to children. About 15,500 units sold on Amazon from June to September 2024 are affected.
Bridgewell Agribusiness recalls 5912MOD-CAU Pre-Blend (lot 220349) due to plastic thread contamination. The dry ingredient was distributed only in New York.
Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.
Riverside Natural Foods is recalling Chocolate Chip Granola Mini Bars due to potential metal contamination. Approximately 2.4 million cases distributed nationwide are affected.