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.
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.
Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.
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.
D'Dioses Coconut Ice Pops (4 oz) may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these substances should not consume the product.
Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.
D'Dioses Cookies Cream Ice Pops may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
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.
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.
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
D'Dioses Fruit Pops, Inc. is recalling Ice Pop D'Dioses Limon 4 oz packages 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.
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.
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.
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.
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.
Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.
ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.
Abiomed, Inc. is recalling ABIOMED Intro Kit heart pump introducer sheaths due to potential leakage from under the sheath cap and along hub score lines. The manufacturing defects are not visually detectable by users.
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.
Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.
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 2022-2027 Vision transit buses because an exhaust hanger pin may damage the hydraulic brake line, causing leaks and increasing fire or crash risks.
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.