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.
Diagnostica Stago is recalling 5,437 units of STA System Control N + P because a positive bias was confirmed on specific calibrator levels.
Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG studies.
Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.
Ferris Coffee and Nut Company is recalling R.H. Macys & Co. Cinnamon Roasted Almonds due to an incorrect product label on the back panel.
Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.
Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.
Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.
Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.
Ameditech is recalling QuickTox 5 Panel Drug Screen DipCards due to mixed products. The recall affects 3,400 units distributed in 13 US states.
Polymer Technology Systems is recalling CVS Health At Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.
Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.
Polymer Technology Systems is recalling 15,118 Walgreens At-Home A1C Test Kits due to a software bug that may display incorrect numerical values for extreme results.
Alliance Tech Medical is recalling All Flow Pulmonary Function Filters because patients reported a bad taste associated with the devices.
Integra Lifesciences is recalling nine Ascension Silicone PIP implants that were mislabeled as size 1 but contained size 0 implants.
Angiodynamics, Inc. is recalling 36 units of MICRO-PSD Electron sensors because they may provide readings outside the expected accuracy range.
Lupin Pharmaceuticals is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules because stability studies showed high out-of-specification dissolution results.
Polymer Technology Systems is recalling ReliOn FastA1C Tests due to a software bug that may display incorrect numerical values instead of expected symbols.
Polymer Technology Systems is recalling A1CNow SELF CHECK devices due to a software bug that may display incorrect numerical values instead of expected symbols.
Medtronic is recalling 24 units of Affinity 38um Arterial Filters due to excess plastic flash above the outlet port.
Rhondium Limited is recalling six OVC3 One Visit Crown devices because they were mislabeled with an incorrect expiration date.
Polymer Technology Systems is recalling A1CNow+ Systems because a software bug may display incorrect numerical values instead of expected symbols.
Bard Peripheral Vascular is recalling 127 Lifestream stents in Australia due to potential difficulty advancing the catheter through a 6F introducer sheath.
T & R Enterprises USA, Inc. is recalling 2 oz. and 3 oz. vegetable eggrolls because they were produced and packaged under insanitary conditions.
Tekia, Inc. is recalling 36 intraocular lenses that may be mislabeled with the incorrect diopter power. No U.S. distribution occurred.