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 Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Nuez Ice Pop bars because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40, which pose a serious health risk to consumers with allergies or sensitivities.
ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.
D'Dioses Mango Ice Pops (3.7 oz) are being recalled because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.
Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
D'Dioses Fresa Leche ice pops may contain undeclared milk, pecans, pistachios, and food colorings (yellow #5 and red #40). The product was distributed in NJ, CT, NY, and PA.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Guayaba ice pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Nanche ice pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators nationwide because affected units may have open or incomplete seals on the packaging, which could compromise sterility assurance.
D'Dioses Rompope ice pops may contain undeclared milk, pecans, pistachios, and food color additives (yellow #5 and red #40). The product was distributed in NJ, CT, NY, and PA.
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
D'Dioses Tamarindo ice pops may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies to these ingredients should not consume the product.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Vainilla ice pops because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The products were distributed in NJ, CT, NY, and PA.
Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115) used in cardiopulmonary bypass procedures due to the discovery of loose foreign material containing trace levels of blood in two units.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Pistachio Ice Pop (1 Bar, 81.7 g) because it may contain undeclared milk, pecans, pistachios, yellow #5, and red #40.
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.
Frutas y Hortalizas del Sur S.A. is recalling Organic Whole Blueberries due to potential E. coli O145:H28 contamination. Affected product is 10 oz frozen blueberry bags distributed in Florida.
Blue Bird is recalling 2022-2027 Vision transit buses because an exhaust hanger pin may damage the hydraulic brake line, causing leaks and increasing fire or crash risks.
Ford Motor Company is recalling certain 2021-2026 Bronco and Bronco Raptor vehicles because the engine compartment wiring harness may short circuit and cause a fire.
Blue Bird is recalling certain 2022-2027 Vision school buses because an exhaust hanger cotter pin may damage hydraulic brake lines, causing leaks that increase the risk of fire or crashes.