The Recall Desk

Archive

June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical
13
Severe
177
High
265
Moderate
57
Low
1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

1–100 of 513

  • SevereNHTSA·23V462000·2023-06-30

    Mercedes-Benz Recalls C300 and AMG C43 for Wiring Harness Defect

    Mercedes-Benz is recalling 2022-2023 C300 and 2023 AMG C43 vehicles because an incorrectly sized transmission wiring harness may cause damage and loss of drive power.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG C43, C 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·027-2023·2023-06-30

    Panamerican Foods Recalls Ineligible Pork and Beef Bean Stew Products

    Panamerican Foods, LLC is recalling approximately 4,978 pounds of pork and beef bean stew products imported from Brazil. The products were imported from an establishment not eligible to export meat to the U.S.

    Product
    Panamerican Foods, LLC Recalls Ineligible Pork and Beef Bean Stew Products Imported from Brazil
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2023·2023-06-30

    House of Raeford Recalls Foster Farms Mini Chicken Corn Dogs for Spoilage

    House of Raeford is recalling Foster Farms mini chicken corn dogs due to possible spoilage. No illnesses have been reported.

    Product
    House of Raeford Farms, Inc. — House of Raeford Recalls Foster Farms Brand Mini Chicken Corn Dog Products Due to Possible Spoilage
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V463000·2023-06-30

    Mercedes-Benz Recalls C 300 and AMG C43 for Wiring Fire Risk

    Mercedes-Benz is recalling 2022-2023 C 300 and 2023 AMG C43 vehicles because improperly secured electrical wiring ground connections may overheat and cause a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E049000·2023-06-30

    Maxzone Recalls DEPO Rear Turn Signal Lights for Size Non-Compliance

    Maxzone is recalling specific DEPO rear turn signal lights that may be smaller than federal safety standards require, potentially reducing visibility to other drivers.

    Product
    EXTERIOR LIGHTING:TURN SIGNAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V464000·2023-06-30

    Mercedes-Benz Recalls EQS Models for Rear Seat Belt Bolt Issue

    Mercedes-Benz is recalling 2022-2023 EQS 450 and 2022 EQS 580 vehicles because rear seat belt buckle bolts may not be secured properly, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 580, EQS 450, EQS450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V460000·2023-06-30

    Stoughton Recalls 2024 CCGN-40T Trailers Due to Brake Hose Defect

    Stoughton Trailers is recalling 2024 CCGN-40T trailers because brake hoses may be the wrong length or lack fasteners, risking brake failure and crashes.

    Product
    STOUGHTON — STOUGHTON CCGN-40T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·23237·2023-06-29

    CaTeam Canvas Baby Hammock Swings Recalled for Suffocation Hazard

    CaTeam is recalling about 700 Canvas Baby Hammock Swings sold online from November 2022 through January 2023 because they violate the Safe Sleep for Babies Act. The inclined design poses a suffocation risk to infants.

    Product
    Canvas Baby Hammock Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V458000·2023-06-29

    2020–2023 Honda Ridgeline Brake Master Cylinder Separation Recall

    Honda is recalling certain 2020–2023 Ridgeline vehicles because a fastener connecting the brake booster and master cylinder may have been improperly assembled, risking brake failure and crashes.

    Product
    HONDA — HONDA, ACURA PASSPORT, RIDGELINE, PILOT, CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23234·2023-06-29

    Bose Acoustimass, Lifestyle, and Companion Bass Modules Due to Fire Hazard

    Bose Corporation is recalling select bass modules manufactured before April 2006 because electrical components can fail and cause fires. The firm has received 21 reports of ignition or melting worldwide, with three resulting in property damage.

    Product
    Bose Acoustimass, Lifestyle and Companion bass modules (produced before April 2006)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23235·2023-06-29

    Victrola Wood Metropolitan Bluetooth Record Players Recalled for Fire Hazard

    Victrola is recalling about 5,700 Wood Metropolitan Bluetooth Record Players because they can overheat and catch fire. The company has received six reports of overheating or fire, including one minor injury and one report of minor property damage.

    Product
    Wood Metropolitan Bluetooth Record Players with 3-Speed Turntables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V457000·2023-06-29

    Hino Recalls 2023 NE7A, NV7A, and NJ7A Trucks for Front Axle Defect

    Hino is recalling 2023 NE7A, NV7A, and NJ7A trucks because over-tightened front axle U-bolts may break, potentially causing loss of vehicle control.

    Product
    HINO — HINO NE7A, NV7A, NJ7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V455000·2023-06-29

    2023 Grand Design travel trailers recalled for improperly tightened axle fittings

    Grand Design is recalling certain 2023 Momentum and Reflection travel trailers with 5200 and 6000 CURT RV axles due to improperly tightened grease fittings that may separate, risking wheel detachment and crashes.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM, REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23771·2023-06-29

    H-E-B Leather Woven Chairs Recalled for Fall Hazard

    H-E-B is recalling about 1,400 Haven & Key Leather Woven Chairs because the backrest and legs can crack and break off when someone is seated, creating a fall hazard. The firm has received 11 reports of cracking or breaking, with no injuries reported.

    Product
    Haven & Key Leather Woven Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0993-2023·2023-06-28

    Wegmans Italian Classics Diavolo Pasta Sauce recalled for undeclared fish allergen

    Wegmans Italian Classics Diavolo Pasta Sauce 24 OZ is being recalled due to undeclared fish content. Fish allergies could pose serious health risks to consumers who consume the product unknowingly.

    Product
    Wegmans Italian Classics Diavolo Pasta Sauce 24 OZ
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-1742-2023·2023-06-28

    Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy

    Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.

    Product
    CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1769-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.

    Product
    CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1755-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.

    Product
    CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1719-2023·2023-06-28

    Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

    Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.

    Product
    ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1725-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure

    Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.

    Product
    ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1738-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy

    Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.

    Product
    CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1796-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

    Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.

    Product
    ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1732-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Energy During Therapy

    Medtronic implantable cardioverter defibrillators (CRT-Ds) may fail to deliver adequate energy during high-voltage treatment due to a manufacturing defect in the feedthrough component, affecting 373 units.

    Product
    CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; 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-1753-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy

    Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.

    Product
    CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic recalls certain ICD and CRT-D defibrillators due to a rare potential for reduced or no-energy output during high-voltage therapy. Affected devices were manufactured with a specific glassed feedthrough component.

    Product
    ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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-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-1793-2023·2023-06-28

    Implantable Defibrillators May Produce Reduced or No Energy Output

    Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed worldwide.

    Product
    ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1735-2023·2023-06-28

    Implantable defibrillators risk energy output failure during high voltage therapy

    Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.

    Product
    CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1714-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output

    Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.

    Product
    ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V453000·2023-06-28

    Freightliner eCascadia Recalled for Electronic Stability Control Software Defect

    Daimler Trucks North America is recalling 2023-2024 Freightliner eCascadia vehicles because the service brake system may incorrectly calculate vehicle mass, impairing electronic stability control performance.

    Product
    FREIGHTLINER — FREIGHTLINER E-CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2023·2023-06-28

    Medtronic ICD COBALT XT implants may deliver reduced or no therapy

    Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.

    Product
    ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1729-2023·2023-06-28

    Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk

    Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.

    Product
    CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1734-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output

    Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.

    Product
    CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1767-2023·2023-06-28

    Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a specific feedthrough defect. The 4,767 affected units were distributed nationwide and worldwide.

    Product
    CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1778-2023·2023-06-28

    Implantable Defibrillators May Deliver Reduced Energy During Therapy

    Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.

    Product
    CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1819-2023·2023-06-28

    Implantable defibrillators may fail to deliver high-voltage therapy during treatment

    Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.

    Product
    ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Energy Output Failure

    Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.

    Product
    CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1727-2023·2023-06-28

    Implantable cardioverter defibrillators may output reduced or no energy during therapy

    Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.

    Product
    ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1740-2023·2023-06-28

    Implantable Defibrillators Risk Loss of Therapy from Feedthrough Defect

    Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.

    Product
    CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2023·2023-06-28

    Medtronic Implantable Defibrillators Risk Failing to Deliver Electrical Therapy

    Medtronic is recalling 404 units of implantable cardioverter defibrillators and cardiac resynchronization devices due to a rare risk of reduced or absent energy output during therapy. The defect involves a specific manufacturing feedthrough component.

    Product
    CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2023·2023-06-28

    Medtronic ICD-VR PRIMO MRI Defibrillators: Potential Therapy Delivery Failure

    Certain Medtronic implantable cardioverter defibrillators and CRT-Ds may fail to deliver adequate energy during high-voltage therapy due to a feedthrough component defect. This affects 5,215 units distributed worldwide.

    Product
    ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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-1777-2023·2023-06-28

    Implantable Defibrillators Recalled for Rare Risk of Energy Output Failure

    Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.

    Product
    CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; 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 (Devices)·Z-1746-2023·2023-06-28

    Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure

    Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.

    Product
    CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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 (Devices)·Z-1782-2023·2023-06-28

    Implantable Defibrillators May Fail During High-Voltage Cardiac Therapy

    Medtronic implantable defibrillators may fail to deliver energy during high-voltage cardiac therapy due to a defective glassed feedthrough component. The recall affects 2,968 units distributed nationwide and worldwide.

    Product
    CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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
  • 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-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-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-1826-2023·2023-06-28

    ARROW Endurance Peripheral Catheters Recalled for Separation and Leakage Risk

    ARROW Endurance Extended Dwell Peripheral Catheters are being recalled due to potential catheter separation or leakage. The recall affects 262,016 units distributed nationwide and in Canada.

    Product
    ARROW Endurance Extended Dwell Peripheral Catheter System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1791-2023·2023-06-28

    Implantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy

    Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.

    Product
    ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1733-2023·2023-06-28

    Medtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure

    Medtronic has recalled 891 implantable cardioverter defibrillators (CRT-D) worldwide due to a rare potential for reduced or absent energy output during defibrillation therapy. Units manufactured with a specific feedthrough component are affected.

    Product
    CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; 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-1722-2023·2023-06-28

    Implantable cardioverter defibrillators recalled for potential therapy delivery failure

    Medtronic implantable cardioverter defibrillators (ICDs) with a specific glassed feedthrough are recalled due to a rare potential for reduced or no energy output during high voltage therapy.

    Product
    ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2023·2023-06-28

    Implantable Defibrillators Risk Reduced Energy Output During Therapy

    Medtronic implantable defibrillators with a specific feedthrough may fail to deliver adequate energy during high voltage therapy. Approximately 476 affected units distributed nationwide and worldwide.

    Product
    CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1776-2023·2023-06-28

    Medtronic Implantable Defibrillators May Fail Therapy Energy Delivery

    Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.

    Product
    CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; 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-1706-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment

    Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.

    Product
    ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1749-2023·2023-06-28

    Implantable Cardiac Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.

    Product
    CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1748-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Therapy During Critical Events

    Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide are affected.

    Product
    CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1766-2023·2023-06-28

    Implantable defibrillators may deliver reduced or no energy during therapy

    Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.

    Product
    CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0990-2023·2023-06-28

    Miyako Select Shredded Crab Meat recalled for undeclared wheat and eggs

    Aquamar Inc is recalling Miyako Select shredded crab meat and related crab-flavored seafood products due to undeclared wheat and eggs allergens. The recall affects approximately 31,079 cases distributed across the United States and Canada.

    Product
    Miyako Select Shredded Crab Meat Keep Refrigerated #1485 Ingredients: Fish Protein (Pollock, Threadfin Bream and/or Flying Fish), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Carrageenan, Natural and Artificial Flavors
    Category
    Food
    Distribution
    12 states
  • 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-1728-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.

    Product
    ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1794-2023·2023-06-28

    FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk

    Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.

    Product
    ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2023·2023-06-28

    Medtronic implantable defibrillators may fail to deliver therapy

    Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.

    Product
    CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1717-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Reduced or No Therapy Output

    Certain Medtronic implantable cardioverter defibrillators and cardiac resynchronization defibrillators may fail to deliver energy during high-voltage therapy due to a specific feedthrough design issue. The recall affects 3,801 units distributed in the US and worldwide.

    Product
    ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.

    Product
    ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1773-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Critical Therapy

    Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.

    Product
    CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1720-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.

    Product
    ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1805-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output

    Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2023·2023-06-28

    Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic's ICD-VR DVME3D4 defibrillators are recalled due to a rare risk of reduced or no energy output during high-voltage therapy. The defect involves a specific feedthrough component and affects approximately 14,989 units distributed nationwide and worldwide.

    Product
    ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1713-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy

    Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.

    Product
    ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1765-2023·2023-06-28

    Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure

    Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.

    Product
    CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1774-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

    Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.

    Product
    CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1799-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure

    Medtronic's implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a feedthrough defect. Approximately 6,821 devices are affected worldwide.

    Product
    ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1737-2023·2023-06-28

    Medtronic Implantable Heart Defibrillators Risk Therapy Delivery Failure

    Medtronic CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.

    Product
    CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1752-2023·2023-06-28

    Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure

    Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.

    Product
    CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1707-2023·2023-06-28

    Implantable Defibrillators Risk Reduced or No Energy Output During Therapy

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.

    Product
    ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1803-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure

    Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2023·2023-06-28

    Implantable defibrillators may fail to deliver high-voltage therapy due to defect

    Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.

    Product
    ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1809-2023·2023-06-28

    Medtronic Implantable Defibrillators May Fail to Deliver High-Voltage Therapy

    Medtronic implantable defibrillators with a specific feedthrough defect may rarely experience reduced or no-energy output during high-voltage therapy. Patients should contact their healthcare provider for evaluation.

    Product
    ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1813-2023·2023-06-28

    Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected nationwide and worldwide.

    Product
    ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; 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-1779-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Critical Heart Therapy

    Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.

    Product
    CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2023·2023-06-28

    Implantable Cardiac Defibrillators May Fail During High-Voltage Therapy

    Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.

    Product
    CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1768-2023·2023-06-28

    Medtronic Implantable Defibrillators Risk Failure to Deliver High-Voltage Therapy

    Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.

    Product
    CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2023·2023-06-28

    Implantable cardiac defibrillators recalled for potential therapy failure risk

    Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component.

    Product
    ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1762-2023·2023-06-28

    Medtronic Cardiac Defibrillators Potentially Fail to Deliver High-Voltage Therapy

    Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may fail to deliver high-voltage therapy due to a defect in specific glassed feedthrough components. The FDA classified this as a Class I recall due to potential for serious harm.

    Product
    CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    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-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

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