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.
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
Dorel Juvenile Group is recalling about 115,700 Cosco Jump, Spin & Play Activity Centers because the straps can detach or break while a child is in the seat, posing fall and injury risks. The company has received 141 reports of strap failures, including 38 minor injuries.
Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date printed on the device label. The company is requesting return of affected units.
MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.
Medline is recalling 58 units of ReNewal Ligasure Maryland Jaw Sealer electrosurgical instruments due to incomplete seals on packaging trays that may allow contamination during reprocessing.
MEDLINE INDUSTRIES is recalling ReNewal Ligasure Sealer/Divider electrosurgical instruments due to incomplete seals on packaging trays. The recall affects 268 units distributed in the United States.
Medline is recalling 11 reprocessed Covidien LigaSure and Ethicon Harmonic electrosurgical devices due to incomplete seals on their packaging trays.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
Dollar Tree Distribution recalled approximately 4.3 million over-the-counter drug products sold by Family Dollar stores nationwide after discovering they were stored outside of labeled temperature requirements.
Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.
LivaNova recalls 37 units of the 3T Heater Cooler System due to incorrect maintenance schedule information in the Quick Reference Guide. No injuries reported.
Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs distributed nationwide in the US and Canada. The specific reason for the recall was not disclosed in the available FDA notice.
BD is recalling certain lots of BACTEC Plus Aerobic/F Culture Vials because some vials have duplicate barcode sequence numbers on their labels. The recall affects 781,600 vials distributed nationwide.
Mazor Robotics has initiated a voluntary recall of 324 MAZOR X robotic guidance systems (Model TPL0059) due to a software issue requiring update. Affected devices were distributed nationwide in the US.
Infinant Health is recalling Evivo infant probiotic products for containing an unapproved food additive. The recall affects 3,257 cartons distributed across 13 US states.
Little Sleepies is recalling approximately 450,000 Sleepyhead Loveys and Bandana Bibs because the care instruction label can detach, posing a choking hazard to young children.
Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.
Dr. Berne's MSM DROPS 5% Solution is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 3833 bottles distributed nationwide and internationally.
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.
Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
Target's Good & Gather Organic Jasmine Rice is being recalled due to rice weevils found in bags. Consumers should not consume affected product.