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.
MicroAire is recalling 29 units of Endotine Transbleph 3.5 because the side label lists an incorrect part number.
The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.
Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.
Beckman Coulter is recalling UniCel DxC Synchron Clinical Systems because the No Foam Bottle Assembly may leak solution.
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.
Sustainable Community Development LLC is recalling Xtra Immunity Brown Rice Antioxidant Probiotic Extract because the dietary supplement contains drug claims, making it misbranded.
LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.
Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause them to appear lumpy and have an unpleasant taste and odor.
Bolthouse Farms is recalling eight varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause the beverages to appear lumpy and have an unpleasant taste and odor.
Beckman Coulter is recalling No Foam DxC reagent because it is incompatible with DxC hydropneumatic parts, potentially affecting UniCel DxC System analyzers.
Terumo CVS is voluntarily recalling HX2 Temperature Management Systems because the Interchlor sanitizer required for cleaning is no longer available.
Bolthouse Farms is recalling 8 varieties of protein drinks because spoilage may cause them to appear lumpy and have an unpleasant taste and odor.
Bayer Healthcare is recalling 42 MEDRAD MRXperion MR Injection Systems because they display a 4205 error message when used with 3T scanners.
Amerx Health Care Corp. is recalling 6,993 units of Amerigel Hydrogel Wound Dressing Advanced Formula because the product did not meet specifications for Zinc Acetate.
The Anspach Effort, Inc. is recalling 18 Anspach G1 High Speed Electric Handpiece Air Cooled units because the graphics indicating locked and unlocked positions are reversed.
Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks because spoilage may cause the beverages to appear lumpy and have an unpleasant taste and odor.
Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.
Martinez Imports is recalling Botanas Los Mart Velitas Candies because samples contained undeclared artificial colors.
Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions is no longer available.