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.
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.
A fuel pipe assembly in 2023-2024 McLaren Artura vehicles may detach, causing fuel leaks that increase the risk of engine fires. Dealers will replace the affected assembly free of charge.
Hyundai is recalling 2019-2024 Nexo vehicles because the hydrogen pressure relief device may fail and leak, creating a fire risk. Owners are advised to park outside until the repair is complete.
Winnebago is recalling certain 2025 Navion and View models, and 2024-2025 Ekko recreational vehicles equipped with GE air conditioners. The soft start device may overheat, increasing fire risk.
Volkswagen is recalling 2024 Atlas and Atlas Cross Sport vehicles because engine bearings may fail, causing engine stalls and increasing the risk of crashes and fires.
Guava Roam strollers are recalled because the brakes can fail to engage or unexpectedly disengage, posing fall and injury hazards to children. No injuries have been reported.
Kyte Baby is recalling about 20,500 Slumber Suits sold from November 2022 to March 2024 because they violate federal flammability regulations for children's sleepwear, posing a risk of burn injuries. No injuries have been reported.
Wolf Appliance is recalling about 44,000 Dual Fuel ranges with infrared griddles due to a short-circuit hazard. Liquid spillage can unexpectedly activate the griddle, posing burn and fire risks. No injuries have been reported.
Baofali 4-in-1 Microfiber Crib Safety Bumpers sold on Temu.com violate the federal crib bumper ban and pose a suffocation hazard to infants. About 390 units were sold from June through August 2024.
Dreamgro Lullaby mermaid travel soothers are recalled because a gold-colored soft star can detach, posing a choking hazard to infants. No injuries have been reported, but one detachment incident was confirmed.
Integra LifeSciences is recalling surgical patties and strips (Model 801451) worldwide due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination.
Reser's Fine Foods recalled Bistro 28 Chicken Street Tacos Express Meal Kits due to Listeria monocytogenes in the cooked chicken. The recall affects 2,880 cases distributed across 31 states.
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
Reser's Fine Foods is recalling Home Chef Chicken Street Taco Kits due to Listeria monocytogenes contamination in the cooked chicken. The kits were distributed across 32 states with use-by dates from September through November 2024.
Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.
Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.
Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.
Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.