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.
Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.
Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.
Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.
Siemens Medical Solutions is recalling 47 Syngo.plaza Picture Archiving and Communication System units to address several software issues.
Tradewind Foods is recalling Goya Honey with Comb because FDA testing found 2,6-Dichlorobenzamide, a chemical not registered for use in honey.
Pharmatech LLC is recalling Senexon Liquid (sennosides) 8.8 mg bottles nationwide as a precautionary measure due to a potential risk of contamination with B. cepacia bacteria.
Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.
Pharmatech LLC is recalling 12,308 bottles of Aller-Chlor Syrup nationwide due to a potential risk of contamination with B. cepacia bacteria.
Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the reagent carousel can misalign and damage the prep probe.
Pharmatech LLC is recalling Senna Syrup due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Four Brothers Packaging is voluntarily recalling Jake's Candy Gummy Worms because the product contains undeclared artificial colors Red 40, Yellow 6, and Blue 1.
Pharmatech LLC is recalling 1,008 bottles of Sennazon (sennosides) Syrup nationwide due to a potential risk of contamination with B. cepacia bacteria.
Pharmatech LLC is recalling Diocto Syrup (docusate sodium) nationwide due to a potential risk of contamination with B. cepacia bacteria.
Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.
Pharmatech LLC is recalling Ninjacof cough syrup due to a potential risk of contamination with B. cepacia bacteria.
Four Brothers Packaging is recalling Jake's Candy Assorted Jelly Fruit Slices because the product contains undeclared FD&C colors Yellow 5 and Blue 1.
Pharmatech LLC is recalling Ninjacof-A liquid due to a potential risk of contamination with B. cepacia bacteria. This is a precautionary measure.
Four Brothers Packaging is voluntarily recalling Jake's Candy Assorted Starlight Kisses Mints because the product contains undeclared FD&C colors Red 40, Blue 1, and Red 3.
EKOS Corporation is recalling 455 EKOS carts because missing washers may cause wheels to wear or dislodge, leading to equipment failure.
Siemens is recalling ADVIA Centaur Calibrator U kits due to failure of analytical sensitivity and drift from internal standardization.
Prismatik Dentalcraft is recalling 150 units of BruxZir Shaded dental restorations because the manufacturer failed to properly identify quarantined lots as such.
R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.
Mckesson Packaging Services is recalling 181 cartons of Lansoprazole capsules due to a label mix-up where the outer packaging was mislabeled.
PAO DE MILHO III, LLC is recalling Triana Family Brioche Donuts Bavarian Cream because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.
Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.