The Recall Desk

Archive

April 2020 recalls

605 recalls were announced in April 2020.

What the numbers show

Critical
6
Severe
113
High
182
Moderate
294
Low
10

Of the 605 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

1–100 of 605

  • HighCPSC·20740·2020-04-30

    Essential Trading Post Recalls Wintergreen and Birch Oils for Packaging Defect

    Essential Trading Post is recalling Wintergreen and Birch Essential Oils because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Essential Trading Post Wintergreen and Birch Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20114·2020-04-30

    Bellman & Symfon Recalls Flash Receivers for Hearing-Impaired Users

    Bellman & Symfon is recalling Flash Receivers because the backup battery may fail to charge, preventing the unit from alerting hearing-impaired users to emergencies.

    Product
    Flash Receivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1746-2020·2020-04-29

    Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-10 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2020·2020-04-29

    Wilson-Cook Recalls HEMO-7 Hemospray Endoscopic Hemostat Devices

    Wilson-Cook Medical is recalling HEMO-7 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break during activation, potentially causing the carbon dioxide cartridge to exit the handle.

    Product
    HEMO-7 Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1769-2020·2020-04-29

    Acutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates

    Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.

    Product
    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1770-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1771-2020·2020-04-29

    Acutus Medical Recalls AcQGuide Flex Steerable Introducer Due to Foreign Material

    Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.

    Product
    Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1793-2020·2020-04-29

    bioMerieux PREVI Isola Printer Power Supply Units Recalled for Fire Hazard

    bioMerieux is recalling PREVI Isola printer power supply units due to a potential fire hazard. The affected units are distributed worldwide.

    Product
    PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2020·2020-04-29

    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 102202101863DO - 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
  • SevereFDA (Devices)·Z-1768-2020·2020-04-29

    Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material

    Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.

    Product
    Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0911-2020·2020-04-29

    H & C Food Inc. Recalls Enoki Mushrooms Due to Listeria Risk

    H & C Food Inc. is recalling 2,500 units of 7.5oz Enoki Mushrooms potentially contaminated with Listeria monocytogenes. The product was distributed in New York, Maryland, and Virginia.

    Product
    Enoki Mushroom; 7.5oz (200g); UPC #831211204181; packed in clear plastic bag with green label; imported from Green Co. located in Korea; distributed from February 15th, 2020 to March 5th, 2020.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·20V243000·2020-04-29

    BMW Recalls 2017-2018 5 Series Vehicles for Head Air Bag Defect

    BMW is recalling 2017-2018 530i, 530e, and 540i vehicles because humidity exposure may impair head air bag deployment, increasing injury risk in crashes.

    Product
    BMW — BMW 540I, 530E, 530I
    Category
    Vehicle
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wires Due to Tracking Issues

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

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
    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-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 a
    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-1789-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures

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

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - 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 (Food)·F-0933-2020·2020-04-29

    Champlain Chocolate Company Recalls Dark Chocolate Coins for Undeclared Milk

    Champlain Chocolate Company is recalling specific lots of Lake Champlain Dark Chocolate Coins because they contain undeclared milk, a major allergen.

    Product
    Lake Champlain CHOCOLATES, COIN DARK BULK ORG, NET WT 48 OZ (1.3 kg), APPROX 186 PIECES, INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, COCOA POWDER (PRESSED WITH ALKALI), AND VANILLA POWDER) MAY CONTAIN TRACES OF MILK, PEANUTS, SOYBEAN, TREE NUTS, AND WHEAT
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1738-2020·2020-04-29

    Boston Scientific Recalls Stretch VL Ureteral Stent Sets

    Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
    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-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, 160/2
    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-1736-2020·2020-04-29

    Boston Scientific Recalls Contour VL Ureteral Stent Sets

    Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
    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
  • HighNHTSA·20V242000·2020-04-29

    MCI Buses Recalled for Seat Belts That May Not Extend

    Motor Coach Industries is recalling certain 2015-2020 buses because seat belts may not extend from the retracted position, rendering them unusable.

    Product
    MCI — MCI D4505, D4000, D4500, J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V241000·2020-04-29

    Volvo VNL and VNR trucks may have loose steering gear fasteners

    Volvo Trucks is recalling certain 2020 and 2021 VNL and VNR trucks because steering gear fasteners may not have been properly tightened. Loose fasteners could result in loss of vehicle control, increasing crash risk.

    Product
    VOLVO — VOLVO VNL, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2020·2020-04-29

    Radiometer ABL90 FLEX Analyzer Recalled for Barcode Reader Error

    Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with software below 3.4MR2 because the barcode reader may misinterpret labels, risking patient mixups and delayed treatment.

    Product
    ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues

    Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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 alo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2020·2020-04-29

    Biomet Shoulder Surgery Pliers Recalled for Sterility Concerns

    Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.

    Product
    Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2020·2020-04-29

    Boston Scientific Recalls Polaris Ultra Ureteral Stent Sets

    Boston Scientific is recalling 19 Polaris Ultra Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2020·2020-04-29

    Smith & Nephew Recalls Footprint Ultra PK Suture Anchors Due to Sterile Breach Risk

    Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.

    Product
    Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2020·2020-04-29

    Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation

    Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or lost samples.

    Product
    ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets

    Boston Scientific is recalling 91 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 6FX24CM with .038 Sensor UPN: M006175262110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2020·2020-04-29

    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor Recall for Sterile Breach Risk

    Smith & Nephew is recalling FOOTPRINT Ultra PK Suture Anchors because excessive movement in packaging could displace the tip protector, potentially causing a sterile breach.

    Product
    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2020·2020-04-29

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall

    Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.

    Product
    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1778-2020·2020-04-29

    Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo SmartCap Tubing because a manufacturing anomaly may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.

    Product
    Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 pu
    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-1752-2020·2020-04-29

    Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues

    Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.

    Product
    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1788-2020·2020-04-29

    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 was used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - 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-1735-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets Due to Tracking Issues

    Boston Scientific is recalling 5 units of Percuflex Plus Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.

    Product
    Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
    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-1751-2020·2020-04-29

    Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity

    Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.

    Product
    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1744-2020·2020-04-29

    Acuvue Oasys for Astigmatism Contact Lenses Recalled for Package Integrity Failure

    Johnson & Johnson Vision Care is recalling specific Acuvue Oasys for Astigmatism contact lenses due to a package integrity failure found during routine testing.

    Product
    ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
    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
  • ModerateFDA (Drugs)·D-1250-2020·2020-04-29

    Lupin Recalls 20 mg Lisinopril Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 20 mg Lisinopril tablets because 10 mg tablets were found inside sealed 20 mg bottles.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Compatibility Data Gaps

    Olympus is recalling 265 Pleuravideoscope units because data validating compatibility with certain endo-therapy devices was missing. Updated manuals are being provided.

    Product
    Olympus Pleuravideoscope, Model LTF-240
    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 label
    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 WITH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1787-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 9,137 temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - 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-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-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 (Drugs)·D-1251-2020·2020-04-29

    Yusef Recalls SPF Lip Moisturizers with Excess Oxybenzone

    Yusef Manufacturing is recalling 12,983 tubes of SPF 15 lip moisturizers because they contain up to 150% of the labeled amount of oxybenzone.

    Product
    PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 841
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1252-2020·2020-04-29

    Lupin Recalls Cefixime Oral Suspension Due to Low Potency

    Lupin Pharmaceuticals is recalling 4,518 bottles of Cefixime for Oral Suspension because a stability study showed the drug was below the required strength.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1739-2020·2020-04-29

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

    Boston Scientific is recalling 40 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 7FX22-30CM with .035 Sensor UPN: M006185157080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2020·2020-04-29

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm

    Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.

    Product
    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
    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-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-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-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 Ol
    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-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-1790-2020·2020-04-29

    CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias

    CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.

    Product
    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1728-2020·2020-04-29

    Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error

    Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.

    Product
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V236000·2020-04-28

    Triumph Recalls Motorcycles Due to Front Brake Pad Corrosion Risk

    Triumph is recalling 3,709 motorcycles because front brake pads may corrode and detach, increasing stopping distance and crash risk.

    Product
    TRIUMPH — TRIUMPH XRX (LRH), STREET TRIPLE RS, SPEED TRIPLE RS, SPEED TRIPLE S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V238000·2020-04-28

    Jayco Recalls 2020 Jay Flight SLX Trailers Due to Propane Leak Risk

    Jayco is recalling 2020 Jay Flight SLX travel trailers because an improperly tightened propane hose may leak, increasing the risk of fire or explosion.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V237000·2020-04-28

    Forest River Recalls 2020 StarTrans PS2 Buses for Seat Belt Defect

    Forest River is recalling 2020 StarTrans PS2 transit buses because seat belt retractors may not secure occupants properly, increasing injury risk in crashes.

    Product
    STARTRANS — STARTRANS PS2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V235000·2020-04-27

    Blue Bird Recalls 2009-2019 Vision Buses for Parking Brake Defect

    Blue Bird is recalling 2009-2019 Vision transit buses because the floor-mounted parking brake may fail to hold the vehicle on an incline when fully loaded.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V234000·2020-04-27

    Blue Bird Recalls School Buses for Parking Brake Defect

    Blue Bird is recalling 2006-2021 Vision and 2007-2013 All American school buses because the parking brake may fail to hold the vehicle on an incline.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, VISION TRANSIT BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V233000·2020-04-27

    MCI J4500 and J3500 Motor Coaches Recalled for Brake Hose Defect

    Motor Coach Industries is recalling 2014-2019 J4500 and 2018-2019 J3500 motor coaches because brake hoses may crack, causing air leaks and increased stopping distances.

    Product
    MCI — MCI J4500, J3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E025000·2020-04-24

    Ford Recalls Replacement Headlamps for 2013-2016 Lincoln MKZ Vehicles

    Ford is recalling specific replacement headlamps for 2013-2016 Lincoln MKZ vehicles because they may have improper beam patterns and missing markings, potentially reducing visibility.

    Product
    LINCOLN — LINCOLN MKZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E026000·2020-04-24

    Denso Fuel Pump Recall for Potential Engine Stall Risk

    Denso is recalling certain fuel pumps where an impeller may crack and deform. This defect can cause the engine to stall while driving, increasing the risk of a crash.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20112·2020-04-23

    Leviton Recalls 50-Ampere Electrical Connectors Due to Shock Hazard

    Leviton is recalling approximately 98,000 50-ampere electrical connectors, plugs, receptacles, and inlets sold in the US and Canada due to mislabeled terminal markings that pose an electrical shock hazard.

    Product
    Leviton 50 ampere, non-NEMA electrical connectors, plugs, receptacles and inlets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V231000·2020-04-23

    McLaren Recalls 2,763 Vehicles for Fuel Tank Corrosion Risk

    McLaren is recalling 2,763 vehicles because a foam pad may corrode the fuel tank, potentially causing a leak and fire risk.

    Product
    MCLAREN — MCLAREN GT, 570 GT, SENNA, 720S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20738·2020-04-23

    LUS Recalls Hair Dryers Due to Electrocution or Shock Hazard

    LUS Distribution Inc. is recalling approximately 2,700 hair dryers and diffusers sold in the U.S. because they lack immersion protection, posing an electrocution or shock hazard if they fall into water.

    Product
    LUS Hair Dryers & Diffusers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0892-2020·2020-04-22

    Mountain Rose Herbs Recalls Kudzu Root Due to Salmonella Risk

    Mountain Rose Herbs is recalling specific lots of Kudzu Root because they may be contaminated with Salmonella. The product was sold nationwide in the US and in Canada.

    Product
    Kudzu Root (Pueraria montana var. lobata), This product was packaged in a clear plastic bag or poly-woven bags sold in bulk form net weight ranges from 4 ounces to 20 pounds. The label is read in parts: "***Kudzu Root***Herbal Supplement **Origin: China** MOUNTAIN ROSE HERBS E
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1214-2020·2020-04-22

    Bi-Est Cream Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Bi-Est cream due to lack of processing control. The product was distributed in Florida.

    Product
    Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state
  • 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
  • SevereNHTSA·20V230000·2020-04-22

    Lode King Prestige Semi-Trailers Recalled for Cargo Winch Mount Defect

    Lode-King is recalling 2015-2021 Prestige SDG53-2 step-deck semi-trailers because cargo winch mounts may fail, allowing cargo to fall off and create road hazards.

    Product
    LODE KING — LODE KING PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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