Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

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.

2351–2375 of 4878

SevereFDA (Devices)·Z-1800-2023·2023-06-28
Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Product
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1822-2023·2023-06-28
Implantable Heart Defibrillators May Fail to Deliver Therapy
Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
Product
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1760-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.
Product
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1823-2023·2023-06-28
ICD defibrillators risk reduced or absent therapy output from feedthrough defect
Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and worldwide.
Product
ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0991-2023·2023-06-28
Kanimi Easy Roll Crab Flavored Seafood Product Recalled for Undeclared Wheat and Eggs
Aquamar Inc is recalling Kanimi Easy Roll Crab Flavored Seafood due to undeclared wheat and egg allergens that pose a serious health risk to allergic consumers.
Product
Kanimi Easy Roll Crab Flavored Seafood Shred Style 91406 VCM Ingredients: Fish Protein (Pollock Whiting and or Threadfin Bream), Water, Potato Starch, Contains less than 2% of the following: Sugar, Modified Food Starch, Liquid Egg White, Salt, Sorbitol, Natural and Artificial Fla
Category
Food
Distribution
12 states
SevereFDA (Devices)·Z-1770-2023·2023-06-28
Cardioverter Defibrillators Recalled: Potential Reduced or No-Energy Output
Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.
Product
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1705-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Product
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1807-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
Medtronic recalls approximately 5,622 implantable cardioverter defibrillators that may produce reduced or no energy output during high-voltage therapy due to a specific feedthrough component defect.
Product
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1795-2023·2023-06-28
Implantable Defibrillators May Deliver Reduced or No Energy During Therapy
Certain Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high voltage therapy. The rare defect affects 16 units distributed nationwide.
Product
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1808-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail During High Voltage Therapy
Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a defect in the electrical feedthrough. The devices risk reduced or no energy output during high-voltage treatment.
Product
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1756-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific feedthrough component.
Product
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1757-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
Product
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0893-2023·2023-06-28
Prescription Drug Recall: Ziprasidone Cartons Contain Wrong Medication
Unit Dose cartons labeled as Ziprasidone Hydrochloride 20 mg were found to contain Dronabinol 2.5 mg instead. Lot T04769 (Exp. 2024/12) was distributed nationwide.
Product
ZIPRASIDONE — ZIPRASIDONE (ZIPRASIDONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0992-2023·2023-06-28
Kanimi Crab Flavored Seafood recalled for undeclared wheat and eggs
Aquamar Inc is recalling Kanimi Crab Flavored Seafood Fancy Shred due to undeclared wheat and eggs allergens. The product may cause serious health effects in consumers with these allergies.
Product
Kanimi Crab Flavored Seafood Fancy Shred Style 92410 Ingredients: Fish Protein (Pollock, Whiting and or Threadfin Bream), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Natural and Artificial Flavors (Hydrolyzed Soy Prot
Category
Food
Distribution
12 states
SevereFDA (Devices)·Z-1801-2023·2023-06-28
Medtronic implantable cardioverter defibrillators recalled for potential reduced-output defect
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
Product
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1806-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design defect.
Product
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1804-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Failure to Deliver Therapy
Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.
Product
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2023·2023-06-28
Medtronic ICD defibrillators may fail to deliver critical therapy
Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.
Product
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1716-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a rare potential for reduced or no energy output during high voltage therapy. Approximately 37,547 units are affected.
Product
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1751-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.
Product
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1736-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.
Product
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1710-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
Product
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1709-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Certain Medtronic ICDs manufactured with a specific feedthrough may fail to deliver high-voltage therapy. Patients should contact their healthcare provider immediately.
Product
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1815-2023·2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail During Critical Therapy
Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.
Product
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1715-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
Product
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide