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.
Rovira Biscuit is recalling 22,114 units of Vanilla Econo, Galletas de Vainilla, over undeclared colours FD&C Yellow #6 and FD&C Red 40.
Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.
Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe because some products in the lot are not passing through a 25ga cannula smoothly.
Glenmark Pharmaceuticals is recalling 96,948 packs of Ondansetron Orally Disintegrating Tablets, 4mg, because the blister packs are not fully sealed and tablets are falling out.
Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.
Ferndale Laboratories is recalling 24,589 units of Mastisol Liquid Adhesive because the butyrate tube cracks during actuation, rendering the product unusable.
Bendon Publishing is recalling 39,171 units of Paw Patrol and Mickey Mouse heart-shaped gummy candies over an unapproved color additive, chlorophyllin copper complex.
A New Life Herbs is recalling 23 bottles of Baby Allergy Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
A New Life Herbs is recalling 275 bottles of Pain Away Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
A New Life Herbs is recalling 278 bottles of Boswellia Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
A New Life Herbs is recalling 49 bottles of Baby Soothe Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
A New Life Herbs is recalling 38 bags of Sinus Cap Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
A New Life Herbs is recalling 48 bags of Organic Ginger Root Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
A New Life Herbs is recalling 144 bottles of Chaga Mushroom Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
A New Life Herbs is recalling 116 bottles of Anti-virus Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.
Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.
Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.
Karabetian Import and Distribution is recalling Zimi Kunefe Ready to Eat over partially hydrogenated oils in foods exported to the US.
Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
Karabetian Import and Distribution is recalling Zimi Puff Pastry French Style over partially hydrogenated oils in foods exported to the US.
A New Life Herbs is recalling 22 bottles of Ear Drops Herbal Supplement over unapproved drug claims on the labeling and misbranding for having no Supplement Facts label.