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.
Pentec Health is recalling Fresenius 1% Amino Acid bags because sterility could not be assured for compounded renal nutritional prescriptions.
TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has an incorrect dosage regime.
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling Poly Hist Forte nasal decongestant tablets because they are underdosed or have an incorrect dosage regime.
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.
Whole Foods Market is recalling Curried Vegan Chick N Salad due to an undeclared soy allergen. The product was sold in six northeastern states.
TG United, Inc. is recalling Mesehist WC cough and cold medicine due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to July 2012 due to reports of excessively high flow rates.
Pentec Health is recalling Proplete 90+ KG dialysate solution because sterility could not be assured. The product was distributed to dialysis centers and directly to patients.
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes because the cuff may leak during surgery, requiring re-inflation or replacement to maintain patient ventilation.
TG United, Inc. is recalling TL Hist DM antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling 1,398 bottles of AMBI cough syrup in five states because the product is underdosed or has an incorrect dosage regime.
Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.
Pentec Health is recalling 59 bags of Proplete 60-69 KG intradialytic parenteral nutrition due to a lack of assurance of sterility.
The Compounding Shop is recalling Tri-Mix Injections because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.
The Compounding Shop is recalling Avastin injectable vials because FDA inspections raised concerns about quality control and sterility assurance.