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.
AVID Medical is recalling 192 Halyard IV Start Kits because the included BD ChloraPrep applicators may have open or incomplete packaging seals.
Kwok Shing, Inc. is recalling 70 boxes of American Ginseng due to potential pesticide contamination. The product was distributed in California.
Philips is recalling SmartPath MRI software due to a defect that can terminate examinations during image reconstruction if system memory is exceeded.
Philips is recalling 15 Achieva XR MRI systems because a software issue can terminate examinations if scan parameters exceed system memory.
Philips is recalling 596 Ingenia Elition MRI systems due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.
WWF Operating Company is recalling So Delicious Dairy Free Salted Caramel Cluster Cashewmilk because it may contain small stones and other hard objects.
AVID Medical is recalling Halyard IV Start Kits because the included BD ChloraPrep applicators may have open or incomplete packaging seals.
Ventec Life Systems is recalling 21 HomeFill Oxygen System cylinders because they lack required medical gas labeling.
Tiffany Food Corp is recalling Hexing Haw Balls candy because it contains the unapproved dye Ponceau 4R.
Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product was distributed nationwide.
F & A Foundation is recalling 600 units of Reign Medical Clench Staple Systems because the device's performance characteristics have not been adequately established.
Elegant Foods is recalling Carrot Cakes because the carrot decorations contain Yellow #5 and Yellow #6, which are not listed on the product label.
Taro Pharmaceuticals is recalling Lidocaine Ointment 5% due to failed content uniformity specifications during stability testing.
Wilson-Cook Medical Inc. is recalling 121,241 units of Hemospray Endoscopic Hemostat due to issues with endoscope adherence and the inability to spray powder.
Straumann USA LLC is recalling 216 GM Helix Implants because the packaging identification does not match the actual implant dimensions.
Boston Scientific is recalling StoneSmart Connect Console power adapters that may fail electrical safety testing due to high grounding resistance.
Well Lead Medical Co. Ltd is recalling SunMed Tracheal Tubes because a 6Fr suction catheter could not pass through the samples smoothly.
Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product is distributed nationwide.
ICU Medical is recalling IV Non-Dedicated Gravity Administration Sets because black specks in the drip chamber may cause healthcare providers to delay therapy.
Embecta Medical II LLC is recalling pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices.
Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide.
ICU Medical is recalling 107,800 oncology sets because drip chambers may contain black specks from the molding process, which could lead to product replacement and therapy delays.
Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product was distributed nationwide in the USA.
ICU Medical is recalling 28,550 oncology sets because drip chambers may contain black specks from the molding process. The discolored material does not enter the fluid path but may cause therapy delays.
Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide in the USA.