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.
Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.
Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.
Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.
BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.
Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.
BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Sun Pharmaceutical Industries, Inc. is recalling 83,188 vials of Testosterone Cypionate Injection due to the presence of particulate matter.
BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.
Tearscience is recalling LipiFlow Thermal Pulsation Systems because the labeled storage temperature does not match tested conditions for the full shelf life.
BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.
Vygon MFG is recalling 30,700 AMS-636 Microbore extension sets because the package displays an incorrect priming volume.
BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
BioMerieux SA is recalling ETEST Vancomycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.
BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.
Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.
BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.
AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.
BioMerieux SA is recalling ETEST Ceftriaxone antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Siemens Medical Solutions is voluntarily recalling 80 ARTISTE MV Systems to install a software update. The devices were distributed throughout the United States.
Teleflex Medical is recalling 7,600 units of Green Non-Latex Robertazzi Nasopharyngeal Airways due to a labeling error. The voluntary recall covers products distributed in the US, Canada, and Mexico.
ReVision Optics is recalling 1,279 Raindrop Near Vision Inlays to update instructions for use regarding irrigation and medication timing.
Bayer HealthCare Pharmaceuticals is recalling A+D Diaper Rash Cream due to a labeling claim issue regarding undeclared excipients.
Lakes Farm Raised Catfish Inc. is recalling approximately 1,695 pounds of frozen catfish products found to contain residues of Malachite Green and Leucomalachite Green.
Ajinomoto Windsor is recalling frozen beef taquitos that may contain rubber and plastic pieces. No illnesses have been reported.