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.
Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.
Treehouse Foods recalls griddle waffles for potential Listeria monocytogenes contamination affecting 9.9 million cases distributed nationwide.
Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.
Treehouse Foods is recalling BREAKFAST BEST griddle waffles nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates from October 1, 2024 through October 11, 2025.
Securitas Healthcare's Arial Server Software versions 11.1.4 through 11.1.6 may fail to notify users when emergency calls are initiated through the Arial Nurse Call System, posing a patient safety risk.
International is recalling 2025 EMV vehicles because a missing circuit breaker may cause the windshield defrosting system to fail, reducing visibility.
Nova Bus recalled 2022-2024 LFS buses for incorrectly installed wheelchair securement systems. The attachment points may be in wrong locations, preventing proper restraint in crashes.
USDA FSIS issued a public health alert for frozen pork mortadella illegally imported from Ecuador. Consumers should discard the product as it lacks required inspection marks.
Tesla is recalling 2024 Model X vehicles because flickering parking lights and low beam headlights may fail to sufficiently illuminate the roadway, increasing crash risk.
PACCAR is recalling 2024-2025 Kenworth and Peterbilt commercial trucks with insufficient axle bearing lubrication, which may cause wheel hub overheating and fire or loss of vehicle control.
Kuntry Kustom RV is recalling 2023-2024 Rich Specialty Sanitation and Office trailers because a faulty air conditioner component may overheat and cause a fire.
McLaren is recalling 163 2021 765LT Coupe vehicles because the rear cabin window may detach due to insufficient adhesive bonding, creating a road hazard.
Forest River is recalling 2025 Concord, Entourage, Freelander, and Leprechaun motorhomes because taillights may overheat and fail to illuminate, increasing crash risk.
Chrysler is recalling specific MOPAR Brake Hydraulic Control Units that may fail, causing loss of anti-lock brakes, stability control, and traction control.
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.
Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.
Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.
Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.
Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.
Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.
Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.
Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.