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.
Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.
Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.
Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.
Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.
Allergan is recalling Refresh Relieva Preservative-Free eye drops because the packaging is missing the instructions for use insert.
Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Piping Rock Health Products is recalling 296 jars of Fitness Labs Organic Coconut Oil due to potential mold contamination. The product was distributed in 34 states and Washington, D.C.
Exactech is recalling 14 Equinoxe Humeral Stem devices because packages may include incorrect Instructions For Use (IFU).
Complete Pharmacy and Medical Solutions is recalling 2,418 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.
The Magstim Company Limited is recalling seven Neurosign 100 Intraoperative Nerve Monitors because they were configured for 240V power instead of the required 120V for the US.
Beckman Coulter is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards due to a label error regarding standard deviation values.
Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.
Complete Pharmacy and Medical Solutions is recalling 2,400 vials of Human Chorionic Gonadotropin 1,250 IU due to a lack of potency testing.
Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and the Instructions for Use.
Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.
Bob Evans Farms is recalling approximately 4,200 pounds of raw Italian pork sausage due to possible contamination with thin blue rubber.
Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.
Sun Valley Foods LLC is recalling 240 drums of diced green chile due to the potential to contain foreign material. The product was distributed in California.
Clerio Vision is recalling one lot of contact lenses because the packaging labeled them as -2.25 power, but the lenses inside are -3.75 power.
Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.
Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.
Ansh Labs is recalling 327 SARS-CoV-2 IgM ELISA kits to update instructions and reduce the risk of false test results.
GAZA is recalling Zapien Hand Sanitizer Gel due to cGMP deviations and sub-potent product from the same facility.
Genus Lifesciences Inc. is recalling Oxycodone Hydrochloride Oral Solution because particulate matter was found in multiple lots. The product was distributed nationwide in the USA.