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.
HABA USA is recalling Rainbow Rattle Grasping and Teething Toys because a glued knot can untie, exposing small parts that pose choking and ingestion risks to young children.
Diamond Wipes International is recalling MD Wipe Outz Numbing Tattoo Wipes because the packaging is not child-resistant, posing a risk of serious injury or death from child poisoning.
Little Loves & Co. is recalling youth clothing sets with drawstrings due to an entrapment hazard that could cause serious injury or death to children.
Excel Industries is recalling about 1,800 accessory LED light kits for Hustler and BigDog ride-on mowers because the light bars can overheat or produce flames.
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
Bell Sports is recalling specific Pit Boss helmets that may lack proper impact protection, increasing injury risk in crashes.
Intersurgical Inc is recalling 21,269 One-Piece Guedel Airway devices because they may be occluded or partially occluded. The devices were distributed in six US states.
Philips is recalling 1,810 Cardiac Workstation 7000 units because they may intermittently provide inaccurate native heart rate data.
Fort Defiance Industries is recalling Automated Field Steam Sterilizers because a water recovery system connector may lose ground continuity, creating an unreliable fault current return path.
Gentherm Medical is recalling 9,714 Blanketrol III thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Gifford's Dairy is recalling specific lots of HomeMaine Power Play Fudge ice cream due to potential rubber contamination.
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile due to potential unexpected variability in endotoxin levels.
Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.
Lidl US is recalling Vitasia Asian Style Wok Spice Mix because a positive test result detected Salmonella in the product.
Medtronic is recalling 257 MiniMed 780G insulin pumps distributed in Europe because chemical cleaning agents may have damaged the devices, risking incorrect insulin delivery.
AVID Medical, Inc. is recalling 40 packs of Halyard LAVH PACK kits because a component was improperly sterilized, potentially causing leaks.
restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.
Arrowhead DE LLC is recalling 4,171 Arrow-LOK Implants because they did not undergo a required gamma radiation dose audit, which could reduce sterility assurance and lead to patient infection.
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.
Nutrient Foods, LLC is recalling 16 kits of Protein Cereal Cocoa Crunch because soy was not declared in the contains statement.
Philips is recalling 796 Cardiac Workstation 5000 units worldwide because they may intermittently provide inaccurate native heart rate data.
Gentherm Medical is recalling 46 Innercool Coolblue Console units because overheating of the 115V CPU board may cause the device to shut down.
Sun Pharmaceutical Industries is recalling 1,968 bottles of Carbamazepine 200mg tablets due to CGMP deviations and black spots found on tablets.