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 deaths or serious injuries are reported, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13451–13475 of 13837

  • SevereFDA (Devices)·Z-2016-2021·2021-07-21

    INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

    Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

    Product
    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1957-2021·2021-07-21

    Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing

    Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.

    Product
    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1974-2021·2021-07-21

    Philips Respironics ventilators recalled for degrading foam and chemical hazards

    Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.

    Product
    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2018-2021·2021-07-21

    Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

    Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.

    Product
    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2048-2021·2021-07-21

    Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure

    RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.

    Product
    Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2076-2021·2021-07-21

    Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall

    Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.

    Product
    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2021·2021-07-21

    Canon Vantage Galan 3T MRI System Recalled for Fire Risk

    Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.

    Product
    Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2021·2021-07-21

    Shoulder prosthesis component distributed with incorrect thickness due to lot swap

    Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.

    Product
    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2056-2021·2021-07-21

    GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images

    GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.

    Product
    Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2078-2021·2021-07-21

    Unifine Pentips Plus pen needles distributed with incorrect needle sizes

    Owen Mumford USA is recalling Unifine Pentips Plus pen needles because two cases of 4mm needles were mistakenly packaged as 8mm needles, which could result in patients receiving incorrect needle sizes for their insulin pens.

    Product
    Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2021·2021-07-21

    HeartWare HVAD Pump Implant Kit Impeller Defect Recall

    HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.

    Product
    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in pat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2064-2021·2021-07-21

    MRI System Patient Orientation Button May Cause Flipped Images

    GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.

    Product
    Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2071-2021·2021-07-21

    Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance

    Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.

    Product
    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2021·2021-07-21

    Medical device software c4D fails to change site upon synchronization

    C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.

    Product
    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2068-2021·2021-07-21

    Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance

    Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.

    Product
    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2021·2021-07-21

    GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue

    GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.

    Product
    SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2079-2021·2021-07-21

    Catheter Sheath Introducer Recalled for Size Labeling Discrepancy

    Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.

    Product
    Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2021·2021-07-21

    MRI System User Interface Error May Cause Incorrectly Flipped Images

    GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.

    Product
    SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2058-2021·2021-07-21

    MRI Imaging System UI Defect May Cause Incorrect Image Orientation

    GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.

    Product
    SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2053-2021·2021-07-21

    MRI Scanner Patient Orientation Button Confusion May Flip Diagnostic Images

    GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.

    Product
    SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2046-2021·2021-07-21

    Canon MRI System Recalled for Flame-Retardancy Component Defect

    Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.

    Product
    Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2021·2021-07-21

    Silicone thoracic/abdominal catheter recall due to potential sterilization defect

    RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.

    Product
    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2070-2021·2021-07-21

    Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance

    Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.

    Product
    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2021·2021-07-21

    SIGNA Artist MRI System Patient Orientation Button May Cause Flipped Images

    GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.

    Product
    SIGNA Artist, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2057-2021·2021-07-21

    GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors

    GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.

    Product
    SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
    Category
    Medical Device
    Distribution
    0 states