Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.
Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.
Medline is recalling 8,773 NAIL KIT (Model DYKM1528) units because the sterile saline wound wash may not have been manufactured to the required sterility assurance level for sterile products.
Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.
Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.
Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.
Agebox is recalling 665 bottles of iKids-Growth Day Formula capsules because they contain undeclared ibutamoren, a drug ingredient not approved for marketing in the U.S.
Navitas Organics is recalling organic chia seeds due to potential Salmonella contamination. The recall affects 114,432 units distributed across 26 U.S. states.
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.
Min Jiang Food Store, trading as Koi Koi Trading, is recalling frozen Fish Ball in 400 g packs because of undeclared wheat and sesame. The FDA has classified this recall as Class I.
Min Jiang Food Store, trading as Koi Koi Trading, is recalling frozen Fish Ball in 200 g packs because of undeclared wheat and sesame. The FDA has classified this recall as Class I.
Prime Food Processing is recalling Dried Croaker Fish, 8 oz, because the fish is uneviscerated. The FDA has classified this recall as Class I, its most serious category.
Ford Motor Company is recalling certain 2025 and 2026 F-250 SD and F-350 SD vehicles due to a potential driveshaft failure that could lead to a loss of power.
Ajinomoto Foods North America is expanding a recall for frozen fried rice, ramen, and shu mai products due to possible glass contamination. No injuries have been reported.
Dupray USA is recalling Dupray Neat Steam Cleaners because the boiler can rupture, posing a risk of burns or serious injury. Consumers should stop using the device immediately and contact the manufacturer for a free replacement safety cap.
General Motors is recalling 2012-2013 Buick Regal vehicles in 23 states due to improper corrosion protection on rear suspension toe links, which may fracture and cause loss of control.
Surreal Brands is recalling Tubby Tots Fizzy Flask Bath Magic bath foam sets because moisture can build up pressure in the container, causing pieces to eject forcefully.
Somgem and Yomin brand lighters are being recalled because they lack required child-resistant mechanisms, posing a risk of serious injury or death from fire and burns.
TheKiddoSpace is recalling approximately 9,400 fingerpainting kits because they contain hazardous substances and regulated phthalates that pose health risks to children.
International is recalling certain 2023-2027 IC Bus CESB school buses because the brake lines may have been installed with incorrect hardware, which can damage the lines and cause a leak.
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.
Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.
Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Lotus Mom Corporation is recalling 56 units of the IKM Aluminum Saucepan 9" with Wooden Handle due to potential leachable lead contamination. The product was distributed in California and Colorado.