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.
StellaLife VEGA Oral Care Rinse (Coconut, Lot #2396) was recalled due to manufacturing process deviations. About 16,587 bottles were distributed nationwide.
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.
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.
Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.
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.
Fire Distributors Plus LLC is recalling Earth Kratom Trainwreck capsules because they contain kratom, an unapproved food additive. Consumers should not use these products.
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.
Aurolife Pharma has recalled Glycopyrrolate Tablets (1 mg) nationwide due to failed impurity and degradation specifications. Affected lot 01421038A1 expires May 2023.
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.
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.
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.
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.
AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.
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.
Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.
HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
John Deere is recalling about 1,600 XUV590E, XUV590M, and XUV590M S4 Gator utility vehicles because fuel can leak from under the fuel cap, creating a fire hazard. No injuries have been reported.
Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray nationwide due to manufacturing process deviations. The firm ceased operations and could no longer conduct required stability studies.