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.
Kroger Specialty Pharmacy is recalling Pomalyst 3 mg capsules dispensed in five states due to a lack of processing controls.
Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
Ziegenfelder Company is recalling Budget $aver Monster Cherry-Pineapple Pops after Listeria monocytogenes was found in the Denver plant environment.
TP Orthodontics is recalling 10 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Kroger Specialty Pharmacy is recalling Perjeta 420 mg/14 mL vials due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.
Volkswagen is recalling 2018 Tiguan vehicles because a loose front ball joint nut may cause steering or stability issues, increasing crash risk.
Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, potentially reducing blood flow in ECMO circuits.
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood flow.
BMW of North America is recalling certain 2018 BMW M5 vehicles because engine control unit software may cause the fuel pump to stop, increasing crash risk.
Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.
Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action limits.
AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.
Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.
Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.
Datascope is recalling nine custom tubing kits because a seal defect in the Better Bladder device may allow air entry, potentially reducing blood flow in ECMO circuits.
Triangle Pharmanaturals LLC is recalling Naturally Kratom Bali Gold capsules because all Kratom products from the company may be contaminated with Salmonella.
Kroger Specialty Pharmacy is recalling Temozolomide 20 mg capsules because of a lack of processing controls. The affected products were dispensed in five states.
Regency is recalling U37 and U39 gas stove fireplaces because the pressure release system can fail, causing explosions and injuries.
Harbor Freight Tools is recalling approximately 1,020,000 14-inch electric chainsaws because the power switch can malfunction, allowing the saw to continue operating after being turned off.
Keystone is recalling 2018 Montana fifth-wheel trailers because the slide-out room switch may lack circuit protection, increasing fire risk.
PACCAR is recalling 2018 Kenworth T270 trucks because an incorrectly installed front wheel hub component may cause bearing failure and wheel separation.
Strehl, LLC is recalling TrailerBlade Fleet trailer skirts because mounting brackets may separate, potentially causing the skirt to detach and increasing crash risk.
Navistar is recalling 2019 International LT heavy diesel trucks because lightweight brake drums may overheat, crack, or separate, increasing crash risk.