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.
General Motors is recalling approximately 193,652 vehicles from 2005-2007 due to a driver's door module defect that could cause a fire.
Temsa is recalling 256 motorcoaches because over-tightened seat belt bolts may fail in a crash, increasing injury risk.
Texsport is recalling about 325 Cedar Lake Propane Heater/Cookers because a malfunctioning regulator can cause propane to flare, posing a fire hazard.
Honda is recalling specific 2006-2007 S2000 and 2006 Acura RSX vehicles because the brake booster may lose vacuum, reducing braking assistance and increasing crash risk.
TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling ED A-Hist Tablets because they are underdosed or have an incorrect dosage regime.
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
Pentec Health is recalling specific lots of IDPN dialysate solution bags because sterility could not be assured. The products were distributed to dialysis centers and directly to patients.
TG United, Inc. is recalling 12,198 bottles of Tri-Dex PE because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
The Compounding Shop is recalling Dexamethasone 10 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling 43 vials of Sodium EDTA Injectable because FDA inspections raised concerns about quality control and sterility assurance.
The Compounding Shop is recalling Methylcobalamin 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The Compounding Shop is recalling Baclofen 500 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
Kreg Medical Inc. is recalling 59 E-Z Wider Bariatric Chair Beds because the bed frame collapsed during patient use, leaving the patient in a forward tilt position.
TG United, Inc. is recalling 2,532 bottles of TL-DEX DM cough suppressant because the product is underdosed or has an incorrect dosage regime.
The FDA is recalling 23,050 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.