The Recall Desk

Archive

June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical
13
Severe
183
High
259
Moderate
57
Low
1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 36% are Severe.

101–200 of 513

  • 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-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 (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…
    Category
    Food
    Distribution
    12 states
  • 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-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-1802-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.

    Product
    ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; 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-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-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-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-1818-2023·2023-06-28

    Medtronic ICD COBALT XT Recalled for Potential Energy Output Failure

    Medtronic has recalled certain implantable defibrillators (ICDs) due to a potential for reduced or no-energy output during therapy. Affected devices may fail to deliver required treatment for dangerous heart rhythms.

    Product
    ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1743-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.

    Product
    CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1790-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a glassed feedthrough defect. The FDA Class I recall involves 240 units.

    Product
    ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; 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-1812-2023·2023-06-28

    Implantable Defibrillators May Have Reduced Energy Output During Therapy

    Medtronic is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may produce reduced or no energy output during high-voltage therapy, potentially preventing treatment delivery.

    Product
    ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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-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-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…
    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
  • SevereFDA (Devices)·Z-1747-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.

    Product
    CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; 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-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-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-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-1775-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure

    Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.

    Product
    CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; 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-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 (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-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-1783-2023·2023-06-28

    Implantable Defibrillator Models May Fail to Deliver Shock Therapy

    Medtronic implantable cardiac defibrillators may fail to deliver electrical therapy during treatment due to a defective feedthrough component. Approximately 1,878 devices are affected.

    Product
    CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; 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-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-1754-2023·2023-06-28

    Implantable Cardiac Defibrillators May Deliver Reduced Energy Output

    Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.

    Product
    CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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-1758-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Therapeutic Shock

    Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially failing to deliver life-saving shocks.

    Product
    CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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-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
  • 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…
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1761-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Energy During Therapy

    Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.

    Product
    CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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-1726-2023·2023-06-28

    Medtronic ICD COBALT DR Potential Reduced Energy Output During Therapy

    Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.

    Product
    ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1989-2023·2023-06-28

    Single use hemostatic clips recalled for clip deployment and mechanical failures

    Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2023·2023-06-28

    Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure

    Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.

    Product
    MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2023·2023-06-28

    Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings

    Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.

    Product
    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1976-2023·2023-06-28

    NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability

    Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.

    Product
    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0998-2023·2023-06-28

    Wegmans Penne Rigate Mozzarella Salad recalled for undeclared milk allergen

    Wegmans Penne Rigate Mozzarella Salad is being recalled due to undeclared milk allergen. Affected products were distributed to stores in New York, Pennsylvania, and Massachusetts.

    Product
    Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ (1 LB 14 OZ) 850 g. Packaged in a plastic container.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1991-2023·2023-06-28

    Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions

    Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.

    Product
    Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1004-2023·2023-06-28

    Julian's Recipe Cauliflower Waffle Sandwiches Recalled for Undeclared Soy Lecithin

    Julian's Recipe CAULI-WAFEL SANDWICHES with turkey sausage and cheddar are being recalled because they contain undeclared soy lecithin, which poses a risk to people with soy allergies. The recall affects 1,786 cases distributed in New Jersey, New York, Florida, and Pennsylvania.

    Product
    Julian's Recipe CAULI-WAFEL SANDWICHES TURKEY SAUSAGE & CHEDDAR,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1992-2023·2023-06-28

    Draeger Resuscitaire Warmer Scale May Display Inaccurate Weight Values

    Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.

    Product
    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2023·2023-06-28

    Hemostatic Clip Device Recalled Due to Deployment Failures

    Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0999-2023·2023-06-28

    Medical Food Product Recalled for Potential Mold Contamination

    enterade Advanced Oncology Formula is recalled due to potential mold development and spoilage. The recall affects 43,336 bottles distributed nationwide.

    Product
    enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after…
    Category
    Food
    Distribution
    47 states
  • HighFDA (Devices)·Z-1978-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recall Due to Endoscope Adhesion Risk

    Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2023·2023-06-28

    Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

    Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
    Category
    Medical Device
    Distribution
    51 states
  • HighNHTSA·23V450000·2023-06-28

    Kidron Refrigerated Truck Bodies Recalled for Fire Risk

    ST Engineering Hackney is recalling 2011-2021 Kidron refrigerated truck bodies because a centrifugal clutch may overheat and break, creating a fire hazard.

    Product
    KIDRON — KIDRON REFRIGERATED BODIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2023·2023-06-28

    Masimo SpO2 Ear Sensor May Produce Inaccurate Oxygen Saturation Readings

    Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-1001-2023·2023-06-28

    FDA Recalls Earth Kratom Red Maeng Da Capsules for Unapproved Additive

    Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom capsules because they contain kratom, an unapproved food additive. Approximately 31,600 pouches were distributed in the United States.

    Product
    EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1979-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk

    Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2023·2023-06-28

    Serrated Blade Applicator Kit packaging may contain wrong applicator size

    Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.

    Product
    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1983-2023·2023-06-28

    Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings

    Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.

    Product
    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-1003-2023·2023-06-28

    Frozen Waffles Recalled: Undeclared Soy Lecithin Allergen Risk

    Julian's Recipe Maple & Brown Butter Cauli-Wafels are being recalled due to undeclared soy lecithin. The product poses a risk to consumers with soy allergies.

    Product
    Julian's Recipe Maple & Brown Butter Cauli-Wafels, 7.41 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0989-2023·2023-06-28

    TYR Anamix Early Years infant formula recalled for undeclared tyrosine

    Nutricia North America is recalling TYR Anamix Early Years infant formula due to undeclared tyrosine. The recall affects 94 cans distributed to 22 states and Puerto Rico.

    Product
    TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1987-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V452000·2023-06-28

    Certain 2021–2025 Lion LionC School Buses Electrical Hardware Recall

    Lion Electric is recalling 2021–2025 LionC school buses due to loose electrical hardware that could cause short circuits and loss of steering or braking power. Contact Lion customer service at 1-855-546-6706 for free replacement.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V449000·2023-06-28

    2022-2023 BMW I4 Recalled for High Voltage Battery Charging Unit Failure

    BMW recalls certain 2022-2023 I4, iX, and i760 models due to a defective high voltage battery charging unit that may not have been properly assembled, potentially causing engine stall while driving.

    Product
    BMW — BMW IX, I4, 760I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1002-2023·2023-06-28

    Julian's Recipe Cauli-Wafels recalled for undeclared soy allergen

    Julian's Recipe Original Cauli-Wafels are recalled due to undeclared soy lecithin. Consumers with soy allergies face risk of allergic reaction.

    Product
    Julian's Recipe Original Cauli-Wafels, 7.41 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1981-2023·2023-06-28

    KARL STORZ sterilization trays recalled for inadequate model-specific instructions

    FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.

    Product
    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2023·2023-06-28

    V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration

    The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.

    Product
    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2023·2023-06-28

    HeartWare Ventricular Assist Device Monitor logfile processing failure

    Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.

    Product
    HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1977-2023·2023-06-28

    FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability

    Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.

    Product
    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1000-2023·2023-06-28

    Earth Kratom Trainwreck Capsules Recalled for Unapproved Food Additive

    Fire Distributors Plus LLC is recalling Earth Kratom Trainwreck capsules because they contain kratom, an unapproved food additive. Consumers should not use these products.

    Product
    EARTH KRATOM TRAINWRECK 150 CAPSULES (UPC: 908193737324) (50 UNITS/CASE) and 300 CAPSULES (UPC: 005821990011) (25 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·23V447000·2023-06-27

    2022-2024 Thor Motor Coach motorhomes recalled for detachable bike racks

    Thor Motor Coach is recalling certain 2022-2024 Tranquility and 2022-2023 Sanctuary motorhomes because the R-bike rack arms may fracture and detach, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TRANQUILITY, SANCTUARY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V448000·2023-06-27

    Lion LionC School Buses Surge Tank Defect May Cause Steering and Braking Loss

    Lion Electric is recalling 2019-2025 LionC school buses due to a surge tank support bracket defect. The tank may crack the firewall and damage high-voltage cables, potentially causing loss of steering assistance, drive power, and braking ability.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E048000·2023-06-27

    Eagle Eyes Recalls Aftermarket Headlights for Peterbilt 389 Vehicles

    Eagle Eyes is recalling specific aftermarket headlights for Peterbilt 389 vehicles because they may not provide sufficient light output, potentially reducing visibility and increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V443000·2023-06-26

    Porsche Recalls Macan and Panamera Models for Seat Belt Anchor Defect

    Porsche is recalling certain 2016-2020 Macan and Panamera models because a rear seat belt anchor screw may not be tightened properly, increasing injury risk in a crash.

    Product
    PORSCHE — PORSCHE MACAN S, MACAN, MACAN TURBO, PANAMERA TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V444000·2023-06-26

    Fuel Pump Failure Risk in 2021-2023 Freightliner and Mercedes-Benz Sprinters

    Daimler Vans USA is recalling 2021-2023 Freightliner Sprinter and Mercedes-Benz Sprinter and Metris vehicles due to a fuel pump defect. The pump may shutdown, causing loss of drive power and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER METRIS, SPRINTER 1500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V446000·2023-06-26

    2022–2023 Porsche 911 GT3 Rear Spoiler Control Software Error

    A software error in the rear spoiler control unit may cause brake lights to activate simultaneously on 2022–2023 Porsche 911 GT3 vehicles, potentially confusing other drivers.

    Product
    PORSCHE — PORSCHE 911 GT3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V445000·2023-06-26

    Mercedes-Benz Fuel Pump May Fail, Causing Loss of Drive Power

    Mercedes-Benz USA is recalling certain 2021–2023 vehicles with faulty fuel pumps that may shutdown and cause loss of drive power. Owners should contact dealers for free replacement.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH AMG SL55, AMG SL63, AMG GT63, AMG GT63 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V439000·2023-06-23

    2023 Lincoln Nautilus Brake System Risk from Defective Rear Shock Absorbers

    Ford is recalling 366 2023 Lincoln Nautilus vehicles due to incorrectly manufactured rear shock absorbers that may damage the brake hose, potentially extending stopping distance and increasing crash risk. Dealers will inspect and replace affected components at no cost.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V441000·2023-06-23

    Volvo Trucks Recall for Loose Steering Gear Fasteners

    Volvo Trucks is recalling 2023-2024 VN, VHD, and VAH trucks because steering gear fasteners may not be properly tightened, risking loss of vehicle control. Dealers will tighten the fasteners at no cost to owners.

    Product
    VOLVO — VOLVO VAH, VHD, VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V438000·2023-06-22

    Altec Recalls 2019-2022 Aerial Devices for Electrical Safety Defect

    Altec is recalling 2019-2022 AT335 aerial devices because an inverter-powered outlet may lack ground-fault protection, increasing the risk of injury or fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23231·2023-06-22

    Research Products Steam Humidifiers Recalled for Fire Hazard

    Research Products is recalling about 36,200 steam humidifiers with faulty electrode connector wires that can loosen, cause arcing, and overheat. The company has received 103 reports of overheating, including 10 residential fires causing over $10 million in damage.

    Product
    Steam Humidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E046000·2023-06-22

    Lippert Recalls 5200 and 6000 CURT RV Axles Due to Grease Fitting Defect

    Lippert is recalling 5200 and 6000 CURT RV axles because improperly tightened grease fittings may separate, potentially causing wheel detachment and increasing crash risk.

    Product
    SUSPENSION:MULTIPLE AXLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23229·2023-06-22

    Zuru Recalls 7.5 Million Baby Shark Bath Toys for Impalement Risk

    Zuru is recalling about 7.5 million Robo Alive Junior Baby Shark bath toys due to hard plastic top fins that pose risks of impalement, laceration, and puncture injuries to children. Twelve reported injuries have been documented, including nine cases requiring stitches or medical attention.

    Product
    Robo Alive Junior Baby Shark Sing & Swim Bath Toys (full-size) and Robo Alive Junior Mini Baby Shark Swimming Bath Toys (mini-size)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23770·2023-06-22

    Infanttech Zooby Video Baby Monitors Recalled for Fire Hazard

    Infanttech is recalling about 17,100 Zooby video baby monitors for cars because the battery can malfunction, overheat, and burst, posing a fire hazard. The company has received three reports of the monitors catching fire, with no injuries reported.

    Product
    Zooby video baby monitors for cars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23227·2023-06-22

    Iron Dietary Supplements Recalled Due to Non-Child-Resistant Packaging

    Nationwide Pharmaceutical is recalling Ferrous Sulfate enteric-coated tablets because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children. About 4,000 bottles were sold at major retailers from December 2022 through January 2023.

    Product
    Ferrous Sulfate (Iron) Enteric-Coated Tablets, 324 mg - 100 Tablet Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23769·2023-06-22

    Havertys Concord Dual Power Recliner Chairs Fall Hazard Recall

    About 930 Havertys Concord Dual Power Recliner Chairs are being recalled because the chair back can detach during use, posing a fall hazard. The firm has received nine reports of detachment, including two with reported injuries to the back, neck, and hip.

    Product
    Havertys Concord Dual Power Recliner Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23230·2023-06-22

    Hurtle Multi-Purpose Helmets Recalled Due to Risk of Head Injury

    Sound Around is recalling about 1,800 Hurtle multi-purpose children's helmets because they do not meet federal safety standards for positional stability and may fail to protect in a crash.

    Product
    Hurtle Multi-Purpose Helmet
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23228·2023-06-22

    Boost The Mood Ceramic Mugs Recalled Due to Fire Hazard

    Ceramic mugs labeled "microwave safe" can spark and catch fire when microwaved due to metallic print. About 26,400 units were sold at Ulta Beauty stores and online from October 2022 through March 2023.

    Product
    Boost The Mood Ceramic Mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23226·2023-06-22

    Poseidon M28A Dive Computers Recalled Due to Water Intake Hazard

    Poseidon M28A Dive Computers can stop working when water enters the device, causing the depth sensor to malfunction and loss of dive data. The firm has received one report of water intake but no injuries have been reported.

    Product
    Poseidon M28A Dive Computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0984-2023·2023-06-21

    Fresh Organic Strawberries Recalled for Potential Hepatitis A Contamination

    Cascade International Foods is recalling approximately 35,686 pounds of Fresh Organic Freezer Strawberries from Mexico distributed in California and Oregon due to potential Hepatitis A contamination.

    Product
    Fresh Organic Freezer Strawberries Mexico with calyx (caps) removed, net wt. 18 lbs., packaged in a T60-800 Polyethylene Homopolymer picking tray. Product is imported and distributed in fresh condition by Cascade International Foods.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0985-2023·2023-06-21

    Van Leeuwen ice cream recalled for undeclared walnuts

    Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.

    Product
    Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM; 14 FL OZ (414 ML); ingredients: cream, milk, dark brown sugar, cane sugar, egg yolks, wheat flour, unbleached flour (wheat flour, malted barley flour), water, cocoa processed with alkali, canola…
    Category
    Food
    Distribution
    10 states

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