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.
HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.
Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.
Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.
HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.
HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.
Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.
Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.
Tesla is recalling certain 2026 Model Y vehicles because the wiper arm hose connector may block the windshield washer nozzles, preventing washer fluid from reaching the windshield and reducing driver visibility.
Jayco is recalling certain 2020-2021 North Point fifth wheel travel trailers because the certification labels may have incorrect tire size information, leading owners to fit the wrong tires.
Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.
Philips is recalling the Ingenia 3.0T CX MRI system due to potential alignment errors in the cross reference line when using the MobiView application to review images. The alignment error could affect image accuracy during review.
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.
Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.
Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
Philips is recalling SmartPath to dStream for XR and 3.0T medical imaging software due to potential alignment errors in cross reference line functionality when reviewing images with the MobiView application.
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.