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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17601–17625 of 40124

  • HighFDA (Devices)·Z-1741-2020·2020-04-29

    Beckman Coulter Power Express Sample Processing System Recall for Biohazard Risk

    Beckman Coulter is recalling 291 Power Express Sample Processing System units due to a software design problem that causes sample splashing and potential biohazard exposure.

    Product
    Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1773-2020·2020-04-29

    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 endoscopic procedures.

    Product
    Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-1734-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets

    Boston Scientific is recalling 32 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues

    Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire with Hydrophilic Tip

    Boston Scientific is recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip due to increased complaints about difficulty tracking over the guidewire.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Sensor 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 102201101463MD - 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
  • ModerateFDA (Devices)·Z-1777-2020·2020-04-29

    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, air bubbles, or water leaks during endoscopic procedures.

    Product
    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1748-2020·2020-04-29

    Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm

    Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.

    Product
    Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2020·2020-04-29

    Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives

    Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.

    Product
    The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1783-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate incoming inspection practices for the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - 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
  • ModerateFDA (Devices)·Z-1737-2020·2020-04-29

    Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues

    Boston Scientific is recalling 57 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.

    Product
    Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data

    Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.

    Product
    Olympus Pleuravideoscope, Model LTF-160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2020·2020-04-29

    Rayner RaySert PLUS Intraocular Lens Injector Recall for Labeling Error

    Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.

    Product
    RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1743-2020·2020-04-29

    Fentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic

    Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kits sold to clinical labs without FDA clearance. The products were mislabeled for diagnostic use but are intended for forensic use only.

    Product
    Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
    Category
    Medical Device
    Distribution
    8 states