Severity 4 of 5
Illness, injury, or structural failure has been reported. 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.
CME America is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.
CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
CME America is recalling 6,320 BodyGuard Microset infusion sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.
Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Autocar is recalling 82 Xpeditor vehicles from 2014-2018 because a frame cross-member may fail, causing supported components to detach and increasing crash risk.
Hafiz Foods is recalling approximately 675 pounds of frozen chicken samosas because the poultry was produced without federal inspection. No adverse reactions have been reported.
Ford is recalling 2020 Escape and Transit vehicles because a defective air bag component may prevent proper inflation during a crash, increasing injury risk.
Ford is recalling 2016-2020 Lincoln vehicles because seat tilt functions may damage air bag wiring, causing unintended deployment or failure to deploy.
Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
Blue Bird is recalling 2018-2021 All-American and 2019-2021 Vision school buses because seat belt anchorages may lack reinforcing washers, increasing injury risk in crashes.
CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.
Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.
EMD Serono is recalling 30,756 vials of Cetrotide because missing rubber stoppers could compromise sterility assurance.
Blue Bird is recalling 2019-2021 Vision and All-American buses because seat belt anchorages may lack reinforcing washers, increasing injury risk in crashes.
Daimler Coaches North America is recalling 2018-2020 Setra motorcoaches because the Electronic Stability Control system can be disabled at unsafe speeds, increasing crash risk.
Curt Manufacturing is recalling Rambler RV Towbars because the axial pivot pin may loosen or fail, potentially causing the hitch to separate and increasing crash risk.
Forest River is recalling specific 2021 Riverstone trailers equipped with an optional generator prep package due to incorrect transfer switch wiring that may cause voltage back feed.
Altec is recalling 2017-2020 aerial devices due to a power take-off that may leak oil onto the exhaust heat shield, increasing fire risk.
Beaming White LLC is recalling Koala Hand Sanitizer because the ethanol content is below the label claim and undeclared isopropyl alcohol is present.
Preferred Pharmaceuticals is recalling 144 bottles of Metformin HCl Extended Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) levels exceeding the Acceptable Daily Intake Limit.