The Recall Desk

Archive

February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical
88
Severe
191
High
354
Moderate
163
Low
19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

1–100 of 815

  • SevereNHTSA·20V120000·2020-02-28

    Pierce Emergency Fire Vehicles Recalled for Aerial Device Cracks

    Pierce is recalling 2019-2020 Arrow XT, Enforcer, Impel, and Velocity fire vehicles because cracks in the aerial device tube may cause it to fall.

    Product
    PIERCE — PIERCE ARROW XT, IMPEL, VELOCITY, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V121000·2020-02-28

    Hyundai Recalls 2013-2014 Sonata Vehicles for Fuel Hose Fire Risk

    Hyundai is recalling 2013-2014 Sonata vehicles because a fuel hose may crack, causing a leak and increasing fire risk. Dealers will inspect and repair the hose free of charge.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V122000·2020-02-28

    Hyundai Recalls 2020 Sonata Vehicles for Incorrect Tire Size Labeling

    Hyundai is recalling 2020 Sonata vehicles because the tire pressure label and owner's manual list an incorrect tire size. This error may lead owners to install the wrong tires, affecting vehicle handling.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V119000·2020-02-28

    Forest River Shasta Trailers Recalled for Tire Clearance Issues

    Forest River is recalling 2020 Shasta SST240TH and SST260TH trailers because tires may contact the wheel well, risking tire failure and loss of control.

    Product
    FOREST RIVER — FOREST RIVER SHASTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20083·2020-02-27

    Lennox Recalls Ductless Heat Pumps Due to Fire Hazard

    Lennox is recalling about 1,650 ductless heat pumps sold in the U.S. because internal electrical components can fail and overheat, posing a fire hazard.

    Product
    Lennox Ductless Single-Zone and Multi-Zone heat pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V116000·2020-02-27

    GM Recalls 2020 Silverado and Sierra 1500 for Brake Caliper Bolt Defect

    General Motors is recalling 20,352 2020 Chevrolet Silverado 1500 and GMC Sierra 1500 vehicles because brake caliper bolts may break, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V115000·2020-02-27

    Altec Recalls 2019 Aerial Devices Due to Fastener Failure Risk

    Altec Industries is recalling 238 specific 2019 aerial devices because high-strength fasteners securing the pedestal to the turntable may fail, potentially causing the pedestal to separate.

    Product
    ALTEC — ALTEC LR760-E70, LR756, LR760, LR758
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20081·2020-02-27

    Step2 Recalls Children's Grocery Shopping Carts Due to Laceration Hazard

    Step2 is recalling about 17,000 Little Helper's children's grocery shopping carts because the baskets can break into sharp pieces, posing a laceration hazard.

    Product
    Little Helper's™ children's grocery shopping carts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1136-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1135-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-0711-2020·2020-02-26

    Hungry Root Dairy Free Garlic Parmesan Sauce Recalled for Undeclared Cashews

    The Honest Stand is recalling Hungry Root Dairy Free Garlic Parmesan Sauce because it contains cashews that were not listed on the physical packaging.

    Product
    Hungry Root Dairy free Garlic Parm sauce, Packaged in 9 oz. polypropylene dip containers with lidding film and lid, packed in 24 count master cases. Distributed by Hungry Root Inc. NY, NY 10003
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0952-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.

    Product
    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0947-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropri
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0942-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriat
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1133-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoca
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0950-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the app
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1131-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V112000·2020-02-26

    Nissan Recalls 2020 Versa Vehicles for Fuel Tank Manufacturing Defect

    Nissan is recalling 2020 Versa vehicles because a manufacturing issue may cause a small hole in the fuel tank seam, potentially leading to a fuel leak and fire risk.

    Product
    NISSAN — NISSAN VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1140-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0850-2020·2020-02-26

    NCS Healthcare Recalls Glycopyrrolate Tablets Due to Impurity Failure

    NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, due to high out-of-specification results for an unknown impurity.

    Product
    Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1134-2020·2020-02-26

    Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters

    Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0708-2020·2020-02-26

    Dragonfly Botanicals Breathe Deep Recalled for Internal Use of Coltsfoot

    Green Water, LLC is recalling Dragonfly Botanicals Breathe Deep dietary supplements because they contain Coltsfoot, which is not to be used internally.

    Product
    Dragonfly Botanicals Full spectrum Breathe Deep 1000mg/oz Dietary Supplement, sold in 0.5 oz, 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1144-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0707-2020·2020-02-26

    Taspen's Organics Breathe Easy Herbal Tincture Recalled for Coltsfoot

    Green Water, LLC is recalling Taspen's Organics Breathe Easy Herbal Tincture because it contains Coltsfoot, which is not to be used internally.

    Product
    Taspen's Organics Breathe Easy Herbal Tincture Dietary Supplement, sold in 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0944-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0945-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.

    Product
    Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accesso
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0951-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling three Trilogy EVO Ventilators in Italy because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0705-2020·2020-02-26

    ABH Nature's Products Recalls All Dietary Supplements for cGMP Violations

    ABH Nature's Products Inc. is recalling all dietary supplements under a consent decree because they were prepared, packed, or held in violation of current good manufacturing practice regulations.

    Product
    All Dietary Supplement manufactured and distributed by ABH Nature's Products Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1129-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1290-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1130-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0946-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.

    Product
    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acces
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2020·2020-02-26

    Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact sterility.

    Product
    Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1333-2020·2020-02-26

    Siemens Uroskop Omnia max Recalled for Collision Control Override Risk

    Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1128-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1272-2020·2020-02-26

    Philips HeartStart AEDs Recalled for Quality Standards Defect

    Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.

    Product
    Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1137-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1142-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0953-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0949-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling five Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1328-2020·2020-02-26

    Philips CombiDiagnost GCF X-ray System Software Recall

    Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0713-2020·2020-02-26

    New Seasons Market Recalls Vegetarian Lasagna Due to Undeclared Soy

    New Seasons Market LLC is recalling 30 units of Vegetarian Lasagna With Gluten-Free Pasta because BBQ sauce containing soy was used instead of marinara, and the label does not declare soy.

    Product
    Vegetarian Lasagna With Gluten-Free Pasta, New Seasons Market brand. Product is packaged in a grab "n" go aluminum containter with a clear dome lid, and labeled with a scale PLU label. UPC 252390 706998. The CORRECT label reads in part: "*** VEGETARIAN LASAGNA WITH GLUTEN-FR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1338-2020·2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0730-2020·2020-02-26

    Safeway Cream Cheese Icing Recalled for Plastic Polymer Contamination

    CSM Bakery Products is recalling 32 lb. pails of Safeway Cream Cheese Icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    32 lb. pail SAFEWAY CREAM CHEESE ICING, MDM # 10203458, Distributed by Safeway Inc. PO Box 99 Pleasanton, CA 94566-0009
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0728-2020·2020-02-26

    CSM Bakery Products Recalls Vanilla Buttercreme Frosting Due to Plastic Contamination

    CSM Bakery Products is recalling 35 lb. pails of Vanilla Xtra Smooth Buttercreme Frosting because pieces of plastic polymer were introduced into the sugar system.

    Product
    35 lb. pail VANILLA XTRA SMOOTH BUTTERCREME FROSTING, MDM # 10203023, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2020·2020-02-26

    Nobel Biocare Recalls Implant Retrieval Instruments Due to Sterility Concerns

    Nobel Biocare is recalling 423 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2020·2020-02-26

    Philips CombiDiagnost PCF X-ray System Software Recall

    Philips is recalling 131 CombiDiagnost PCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.

    Product
    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2020·2020-02-26

    Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift

    Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.

    Product
    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instrument Recall Due to Sterility Concerns

    Nobel Biocare is recalling 31 units of Implant Retrieval Instrument CC 3.0 31 mm because a packaging sealing defect may compromise sterility.

    Product
    Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2020·2020-02-26

    Nobel Biocare Recalls Screw Taps Due to Packaging Seal Defects

    Nobel Biocare is recalling Screw Tap Tapered WP Single-Pat devices because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0709-2020·2020-02-26

    Taspen's Organics Respiratory Tea Recalled Due to Coltsfoot Ingredient

    Green Water, LLC is recalling Taspen's Organics Respiratory Tea because it contains Coltsfoot, an ingredient not intended for internal use.

    Product
    Taspen's Organics Respiratory Tea, sold in 2 oz packages
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2020·2020-02-26

    Nobel Biocare Dense Bone Drill Recall Due to Sterility Concerns

    Nobel Biocare is recalling Dense Bone Drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new scr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1275-2020·2020-02-26

    Polysorb Suture Recall Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0712-2020·2020-02-26

    Ardent Mills Recalls Kroger Flour Due to Salmonella Contamination Risk

    Ardent Mills LLC is recalling Kroger Unbleached All Purpose Enriched Flour because it may be contaminated with Salmonella.

    Product
    Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0943-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1341-2020·2020-02-26

    Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring

    Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.

    Product
    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1232-2020·2020-02-26

    Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.

    Product
    Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2020·2020-02-26

    CSM Bakery Products Recalls Frozen Chocolate Chip Cookie Dough Due to Plastic

    CSM Bakery Products is recalling specific lots of frozen chocolate chip cookie dough because pieces of plastic polymer were introduced into the sugar system.

    Product
    30 lb. cases of 480 1.0 oz frozen chocolate chip cookie dough, MDM # 10194622, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2020·2020-02-26

    Philips Respironics Recalls LifeVent EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 29 LifeVent EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate access
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0725-2020·2020-02-26

    CSM Bakery Products Recalls Simplicious Cream Cheese Icing Due to Plastic Contamination

    CSM Bakery Products is recalling 18 lb. pails of Simplicious Cream Cheese Icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    18 lb. pail SIMPLICIOUS CREAM CHEESE ICING 18#PL, MDM # 10202840, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0717-2020·2020-02-26

    Forest View Bakery Cheesecake Recalled for Undeclared Allergens

    Forest View Bakery is recalling cheesecakes with poppy seeds due to undeclared milk, almond, and wheat allergens.

    Product
    Forest View Bakery Cheesecake with Poppy seeds in 18oz plastic clam shell UPC 745454333860
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1273-2020·2020-02-26

    Smith & Nephew Recalls TwinFix Ti Suture Anchors Due to Sterility Risk

    Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube failure may have breached the sterile barrier.

    Product
    TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects

    Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.

    Product
    Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2020·2020-02-26

    Cardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns

    Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile. This could increase the risk of surgical site infections.

    Product
    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1298-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2020·2020-02-26

    Nobel Biocare Guided Tapered Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V111000·2020-02-26

    Custom Fire Recalls 2017 Side Mount Pumper for Foam Pump Overheating

    Custom Fire is recalling one 2017 Side Mount Pumper because the foam pump system can overheat and fail, making firefighting foam unavailable.

    Product
    CUSTOM FIRE — CUSTOM FIRE SIDE MOUNT PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0710-2020·2020-02-26

    Hart Freeze Pack Recalls Diced Zucchini for Listeria Contamination

    Hart Freeze Pack, LLC is recalling 114,480 pounds of diced zucchini due to potential Listeria monocytogenes contamination. The product was distributed in California and Ohio.

    Product
    3/8" diced IQF zucchini in 45 pound poly lined carton
    Category
    Food
    Distribution
    2 states
  • HighCPSC·20078·2020-02-26

    Safavieh Recalls Aura and Silas Chests Due to Tip-Over Hazards

    Safavieh is recalling Aura and Silas 3-drawer chests because they can tip over or entrap children if not anchored to the wall.

    Product
    Aura and Silas 3-Drawer Chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2020·2020-02-26

    CSM Bakery Products Recalls Donut Icing Due to Plastic Polymer Contamination

    CSM Bakery Products is recalling 43 lb. pails of White 'n Glossy Icing donut icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    43 lb. pail WHITE 'N GLOSSY ICING donut icing, MDM # 10203280, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2020·2020-02-26

    FDA Recalls Polysorb Suture Due to Packaging Integrity Concerns

    The FDA is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that could impact sterility.

    Product
    Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20079·2020-02-26

    Home Depot Recalls 4-Drawer Whitewash Chests Due to Tip-Over Hazards

    Home Depot is recalling approximately 200 4-Drawer Whitewash Chests because they are unstable if not anchored to the wall, posing tip-over and entrapment hazards.

    Product
    Home Decorators Collection Print Block 4-Drawer Whitewash Chest
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0716-2020·2020-02-26

    Forest View Bakery Coffee Torte Recalled for Undeclared Soy and Wheat

    Forest View Bakery is recalling Coffee Torte products due to undeclared soy and wheat allergens. Five units were sold at four Chicago retailers.

    Product
    Forest View Bakery Coffee Torte in 18oz plastic clam shell UPC 745454333563
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0724-2020·2020-02-26

    Safeway Chocolate Buttercreme Base Recalled for Plastic Polymer Contamination

    CSM Bakery Products is recalling 45 lb. boxes of Safeway Chocolate Buttercreme Base because pieces of plastic polymer were introduced into the sugar system.

    Product
    45 lb. box SAFEWAY CHOCOLATE BUTTERCREME BASE, MDM # 10201865, Distributed by Safeway Inc. PO Box 99 Pleasanton, CA 94566-0009
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2020·2020-02-26

    Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.

    Product
    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1279-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.

    Product
    Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1331-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Collision Control Override Risk

    Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V113000·2020-02-26

    Thomas Built Buses Saf-T-Liner C2 Recall for Exterior Light Failure

    Daimler Trucks North America is recalling 2017-2020 Thomas Built Buses Saf-T-Liner C2 school buses because the exterior warning lights and stop sign may fail, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0723-2020·2020-02-26

    CSM Bakery Products Recalls Donut Icing Due to Plastic Polymer Contamination

    CSM Bakery Products is recalling 43 lb. pails of Glossy White Icing distributed by Krispy Kreme because pieces of plastic polymer were introduced into the sugar system.

    Product
    43 lb. pail GLOSSY WHITE ICING (1102507) donut icing, MDM # 10199098, Distributed by Krispy Kreme Doughnut Corporation 1814 Ivy Avenue, Winston-Salem, NC 27105
    Category
    Food
    Distribution
    Distributed nationwide

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