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.
Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.
Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.
Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.
ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential ethylene glycol residue.
ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial due to potential small amounts of ethylene glycol residue.
Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Organic Apple Peach, due to the potential presence of mold.
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 Pipeline and Pipeline Flex Embolization Devices because they were shipped with EU-version Instructions for Use.
Ohm Laboratories is recalling Equaline loratadine tablets because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.
Ohm Laboratories is recalling specific lots of loratadine tablets because they failed potency testing. Consumers should stop using the affected medication.
Win Luck Trading Inc is recalling Grove Grow Notes Glutinous Rice because it contains undeclared alcohol. The product was distributed in New Jersey.
The Mentholatum Company is recalling WellPatch Capsaicin Pain Relief Patches because the word 'not' was missing from safety instructions, potentially leading to improper use.
Ohm Laboratories is recalling Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets because they failed potency testing.
Synthes (USA) Products LLC is recalling 36 units of VA-LCP Humerus Plates because one part number was incorrectly etched on the device.
Toshiba is recalling 459 Aquilion CT Systems because specific scanning operations may prevent raw data from being saved.
Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Pear, due to the potential presence of mold. The recall affects 34,573 cases distributed in the US and Canada.
Ohm Laboratories is recalling specific batches of loratadine orally disintegrating tablets because they failed potency testing. Consumers should stop using the affected products.
Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Ohm Laboratories is recalling 311 boxes of Allergy Relief (Loratadine) tablets due to an out-of-specification assay result.
Perez Casas Enterprises is recalling Candy El Pecas Mango Chile due to undeclared Yellow #5 and Red #40 dyes.
Materne North America is voluntarily recalling GoGo SQueeZ Applesauce products due to the potential presence of mold. Consumers should check their pantries for affected lots.
Arrow International Inc is recalling 4FR Single Lumen Pressure Injectable PICC catheters because the instructions state they withstand 10 pressure injections, but they are only tested for 5.
Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Strawberry, due to the potential presence of mold.
Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, due to the potential presence of mold.
Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.