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.
Van Hool is recalling 2015-2018 motorcoaches because seat belt buckle casings may fail, exposing the buckles and reducing the likelihood of seat belt use.
H-E-B is recalling GTC halogen light bulbs because they can shatter while in use, posing laceration and fire hazards.
Residential Elevators Inc. is recalling about 3,700 traction elevators installed in homes between January 2015 and April 2017 because the cab can rise unexpectedly to the top of the shaft, posing an impact hazard.
Mercedes-Benz is recalling specific 2017-2018 C-Class and E-Class vehicles because front seatbacks may not lock properly, increasing injury risk in a crash.
FCA US LLC is recalling 2018 Alfa Romeo Stelvio vehicles because water leaks into the body control module, causing electrical malfunctions that increase crash risk.
Octane Fitness is recalling about 570 XT-One elliptical cross trainers because the incline lead screw can shear off, causing foot pedals to drop unexpectedly and creating a fall hazard.
Primo is recalling hTrio beverage dispensers because hot water may leak at high altitudes, posing a burn risk.
NxStage Medical is recalling 1,243,400 units of PureFlow B Solution because the original labeling failed to warn against mixing dialysate formulations.
Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.
Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, preventing proper programming.
Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.
Centurion Medical Products is recalling Excision Trays used for IV placement and securement. The recall is classified as Class II by the FDA.
Boston Scientific is recalling specific Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.
ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat in certain settings.
Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.
Maplehurst Bakeries is recalling frozen Italian bread dough because a raw material supplier reported potential Listeria monocytogenes contamination in wheat gluten.
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.
Bovie Medical is recalling 5,416 J-Plasma handpieces worldwide because an incomplete cable seal could allow patient fluid backflow, creating a cross-contamination risk.
Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.
Maplehurst Bakeries is recalling frozen 100% Whole Wheat Bread Dough because a raw material supplier reported potential Listeria monocytogenes contamination.
Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.
ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.
ASR Group International Inc. is recalling approximately 50,000 wet pounds of Tank Truck #1 Sugar Syrup because it may contain foreign metal material.
Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.
Bovie Medical is recalling 1,005 J-Plasma Precise OPEN units worldwide because a cable plug defect may cause an incomplete helium seal, risking cross-contamination.