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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11751–11775 of 27470

  • SevereFDA (Devices)·Z-1541-2021·2021-05-19

    Meridian Revogene RNA Software Upgrade Kits Recalled Due to False Negatives

    Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1540-2021·2021-05-19

    Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results

    Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2021·2021-05-19

    GE Healthcare Recalls NM/CT 870 DR Scanners for Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.

    Product
    NM/CT 870 DR Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2021·2021-05-19

    Atos Medical Recalls Provox Life Night HME Devices Due to Insertion Risk

    Atos Medical AB is recalling Provox Life Night HME devices because they may be incorrectly inserted, potentially blocking the patient's stoma.

    Product
    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1534-2021·2021-05-12

    Greiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume

    Greiner Bio-One is recalling VACUETTE blood collection tubes because insufficient draw volume may cause erroneous coagulation test results.

    Product
    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2021·2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.

    Product
    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
    Category
    Medical Device
    Distribution
    0 states