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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

13901–13925 of 27500

  • HighFDA (Devices)·Z-1772-2020·2020-04-29

    Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.

    Product
    Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2020·2020-04-29

    Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.

    Product
    Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2020·2020-04-29

    Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during procedures.

    Product
    Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1779-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2020·2020-04-29

    Radiometer TCM4 Base Unit Recalled for Display Flickering and Unresponsiveness

    Radiometer Medical ApS is recalling 84 TCM4 Base units due to reports of display flickering and unresponsiveness, which may delay patient monitoring.

    Product
    TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 1,929 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2020·2020-04-29

    Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo SmartCap Tubing kits due to a manufacturing anomaly that may cause inadequate insufflation or water leaks during endoscopic procedures.

    Product
    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 700 temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2020·2020-04-29

    KT Health Recalls Ice/Heat Massage Balls Due to Leak Risk

    KT Health, LLC is recalling 94,554 KT RECOVERY+ Ice/Heat Massage Balls because overheating may cause leaks, potentially exposing users to hot fluid.

    Product
    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1717-2020·2020-04-22

    Sysmex CV-11 Sample Unit Recalled for Combustion Hazard

    Sysmex America is recalling 40 CV-11 Sample Units because urine spills on the transport track can reach electrical components, creating a potential for smoke, sparks, and combustion.

    Product
    Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1700-2020·2020-04-22

    Abbott Recalls Merlin PCS 3650 Software Upgrade Kit Due to Anomaly

    Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit because a software anomaly may cause the device to use a previously programmed shock energy level without alerting the user.

    Product
    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1703-2020·2020-04-22

    Sysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard

    Sysmex America is recalling 93 CF-70 instruments because a software mismatch may prevent the device from halting when the cover door is opened.

    Product
    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2020·2020-04-22

    Medtronic NavLock Tracker Recalled Due to Incorrect Assembly

    Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.

    Product
    NavLock Tracker *** Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1699-2020·2020-04-22

    Stago STA-Deficient VIII Plasma Recalled for Cross-Contamination Risk

    Diagnostica Stago is recalling STA-Deficient VIII plasma due to a risk of sample-to-sample cross-contamination that may cause falsely increased factor VIII levels.

    Product
    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2020·2020-04-22

    Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer

    Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.

    Product
    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1716-2020·2020-04-22

    Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect

    Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.

    Product
    Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1692-2020·2020-04-22

    Encore Medical Recalls djosurgical Linear Neck Trials Due to Retaining Ring Failure

    Encore Medical is recalling 28 djosurgical Linear Neck Trials because the retaining ring has a potential to fail inter-operatively.

    Product
    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1679-2020·2020-04-15

    Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose

    Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.

    Product
    ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1629-2020·2020-04-15

    Zeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass

    Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.

    Product
    Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1678-2020·2020-04-15

    Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems

    Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.

    Product
    MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1680-2020·2020-04-15

    Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk

    Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.

    Product
    PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1677-2020·2020-04-15

    Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect

    Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.

    Product
    ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1684-2020·2020-04-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall

    Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.

    Product
    ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide