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.
Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.
SB FOOD LLC is recalling Yoyo Gummy Tropical Flavor candy because it contains Carmoisine (E122), a color additive not approved for use in this product. The recalled product was distributed to 15 states.
Edermy LLC is recalling the PIE Trolley System, model 2005, because the device lacks 510(k) clearance from the FDA.
Agiliti Health - Ellis is recalling Adapt Pumps (Model 61600200) because the Microclimate Management function may fail to re-engage after using the Autofirm function.
Valley Springs Artesian Gold, LLC is recalling 7,840 units of its 1-gallon bottled water due to water being bottled under insanitary conditions. No illnesses have been reported.
Valley Springs Artesian Gold, LLC is recalling Valley Springs Steamed Distilled Water because it was bottled under insanitary conditions.
Lubna Quality Products Inc. is recalling 400 cases of mung beans distributed in Texas and Louisiana due to the presence of Thiamethoxam pesticide.
General Motors has recalled multiple Chevrolet, GMC, Cadillac, and Buick vehicles from 2025–2027 because their radios were not properly configured to download the electronic owner's manual during production. Without the manual, owners may not know how to safely operate the vehicle.
Lotus Mom Corporation is recalling Aluminum Kadai with Metal Handles (Size 5) due to the potential for lead leaching.
Toyota is recalling certain 2026 Corolla vehicles due to missing headlight aim markings that can result in improperly aimed headlights, increasing crash risk and glare for oncoming drivers.
KPCM New York is recalling 720 bottles of Preema brand food colour powders because they contain the banned colour carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40.
Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.
Domino Foods is recalling 2,023 cases of Sodexo Stars Saccharin (Pink) Packets over undeclared aspartame.
Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.
Laerdal Medical is recalling 1,202 Compact Suction Unit 4 RTCA units because those made in a limited period may emit electromagnetic noise beyond the acceptable RTCA limits.
Unichem Pharmaceuticals USA is recalling 60,000 Doxazosin Tablets, USP 4 mg, because the tablets are imprinted with the wrong ID.
Alphatec Spine is recalling 7 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.
Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.
Pro Numb Tattoo Numbing Spray LLC is recalling Pro Numb Tattoo Numbing Spray For Sensitive Skin, 4% Lidocaine, over cGMP deviations.
Pro Numb Tattoo Numbing Spray LLC is recalling Pro Numb Tattoo Numbing Spray, 5% Lidocaine, over cGMP deviations.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the CleverCut Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0725, because devices which did not undergo thermoforming could deform and lose performance.