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.
Anatox Inc has recalled Sonne's Detoxificant #7 due to elevated lead levels. The voluntary recall affects approximately 2,870 bottles distributed in multiple states.
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
DoloEar Earache Drops are being recalled due to manufacturing practice deviations. Homeocare Laboratories voluntarily initiated the recall, which was terminated in September 2024.
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.
Anatox Inc is recalling VIT-RA-TOX Calphonite #38 and Sonne's Calphonite #2 due to elevated lead levels. A total of 6,777 bottles distributed across 27 states are affected.
Great Lakes Coca-Cola Distribution LLC is recalling Fanta Orange 12-pack cases distributed in California because packages labeled zero sugar actually contain full sugar. Consumers relying on accurate labeling for dietary reasons should not consume affected products.
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.
H-E-B is recalling about 1,400 Haven & Key Leather Woven Chairs because the backrest and legs can crack and break off when someone is seated, creating a fall hazard. The firm has received 11 reports of cracking or breaking, with no injuries reported.
Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.
Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.
Fire Distributors Plus LLC is recalling Earth Kratom Trainwreck capsules because they contain kratom, an unapproved food additive. Consumers should not use these products.
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
Aurolife Pharma has recalled Glycopyrrolate Tablets (1 mg) nationwide due to failed impurity and degradation specifications. Affected lot 01421038A1 expires May 2023.
Poseidon M28A Dive Computers can stop working when water enters the device, causing the depth sensor to malfunction and loss of dive data. The firm has received one report of water intake but no injuries have been reported.
AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.
Airstream is recalling certain 2023 Bambi travel trailers due to an overstated freshwater tank capacity that resulted in an incorrect cargo carrying capacity label. The mislabel could lead to unintentional overloading and increased crash risk.
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
Conagra Brands is recalling approximately 2,717 pounds of frozen Marie Callender's Beef Shepherd's Pie due to possible contamination with clear, flexible plastic.