The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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14601–14625 of 39988

  • HighFDA (Devices)·Z-1568-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2021·2021-05-19

    Step-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts

    Step-Har Medical is recalling two Alaris Pump Modules serviced with non-original bezel repair parts that may crack or separate, potentially causing infusion errors.

    Product
    Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1552-2021·2021-05-19

    Bard PowerPort duo M.R.I. Implantable Port Recall for Catheter Issues

    Bard Peripheral Vascular Inc. is recalling 287 PowerPort duo M.R.I. Implantable Ports due to catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2021·2021-05-19

    GE Healthcare Recalls NM/CT 850 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 850 scanners because a specific workflow may cause a 5cm shift in CT radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 850 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2021·2021-05-19

    Abbott NeuroTherm Radiofrequency Generator Recalled for Capacitor Failure

    Abbott is recalling 318 NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that may cause output loss or smoky odors.

    Product
    NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1530-2021·2021-05-19

    St. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress

    St. Jude Medical is recalling Assurity and Endurity pacemakers because a manufacturing issue with epoxy mixing may allow moisture to enter the device, potentially causing malfunction.

    Product
    ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2021·2021-05-19

    ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect

    ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.

    Product
    REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2021·2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc is recalling 189 units of PowerPort duo MRI Implantable Ports due to potential catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2021·2021-05-19

    ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage

    ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2021·2021-05-19

    GE Healthcare Recalls NM/CT 860 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 860 scanners because a specific protocol may cause a 5cm shift in radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 860 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2021·2021-05-19

    Infusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts

    Infusion Pump Repair is recalling 15 Alaris Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, causing infusion errors.

    Product
    Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1550-2021·2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc. is recalling 2,194 PowerPort duo M.R.I. Implantable Ports due to potential catheter flushing, infusion, and aspiration difficulties, as well as septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2021·2021-05-19

    St. Jude Medical Recalls Endurity Pacemakers Due to Epoxy Manufacturing Issue

    St. Jude Medical is recalling 95,042 Endurity pacemakers because a manufacturing issue with epoxy may allow moisture ingress, potentially causing device malfunction.

    Product
    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2021·2021-05-19

    ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect

    ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1585-2021·2021-05-19

    ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect

    ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2021·2021-05-19

    ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

    ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1577-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect

    ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide