Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
Crispy Bagel Co. is recalling Blueberry Artificially Flavored Bagels sold at Lidl for containing undeclared sesame. Approximately 3,020 units were distributed to stores in Virginia, North Carolina, and Maryland.
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).
Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.
Pearson Foods Corporation is recalling romaine lettuce due to potential contamination with deer feces. The affected product was distributed in Illinois, and consumers should not consume it.
Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.
Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).
Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.
Frito-Lay is recalling specific batches of Doritos Nacho Cheese Flavored Tortilla Chips because they may contain undeclared soy and wheat, which are major allergens.
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.
Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.
Every Plate is recalling Green Curry Paste (1 oz, 28g) in meal codes 87 and 116 due to spoilage from temperature abuse. The affected product was distributed to customers in eight states.
Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.