The Recall Desk

Archive

August 2020 recalls

436 recalls were announced in August 2020.

What the numbers show

Critical
25
Severe
99
High
182
Moderate
122
Low
8

Of the 436 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

1–100 of 436

  • CriticalUSDA FSIS·022-2020·2020-08-31

    Ukrop's Recalls Chicken Salad for Undeclared Almond Allergen

    Ukrop's Homestyle Foods is recalling 1,202 pounds of chicken salad due to misbranding and an undeclared almond allergen. No adverse reactions have been reported.

    Product
    Ukrop's Homestyle Foods — Ukrop's Homestyle Foods Recalls Chicken Salad Product Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·20V526000·2020-08-31

    MCI Recalls 2017-2020 J4500 Motor Coaches for Coolant Hose Failure

    Motor Coach Industries is recalling 2017-2020 J4500 motor coaches because a coolant hose may fail, causing engine shutdown and coolant spills that increase crash risk.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V521000·2020-08-28

    Heartland Bighorn Traveler landing legs may collapse causing trailer to drop

    Certain 2019-2021 Heartland Cyclone, 2020-2021 Bighorn Traveler, and 2020-2021 Elkridge recreational trailers may have insufficient bracing on the front landing legs, which could buckle and collapse while parked, causing the trailer to drop unexpectedly.

    Product
    HEARTLAND — HEARTLAND CYCLONE, ELKRIDGE, BIGHORN TRAVELER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V523000·2020-08-28

    Grand Design Solitude recreational trailers recalled for propane gas leak risk

    Grand Design Solitude recreational trailers (2017-2021) are being recalled because the propane supply line may contact the refrigerator burner tube, potentially causing a propane gas leak and increasing fire risk.

    Product
    GRAND DESIGN — GRAND DESIGN SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V522000·2020-08-28

    PJ Trailers DE Trailer Hydraulic Cylinder Bolts May Fail

    PJ Trailers is recalling 2020-2021 DE model trailers. The attachment bolts securing the hydraulic cylinder may fail when the dump box is operated, creating a risk that the box could suddenly drop and injure a person.

    Product
    PJ TRAILERS — PJ TRAILERS DE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V519000·2020-08-27

    Kia Recalls Optima and Sorento Models for Brake Fluid Leak Fire Risk

    Kia is recalling 2013-2015 Optima and 2014-2015 Sorento vehicles because brake fluid may leak inside the Hydraulic Electronic Control Unit, potentially causing an electrical short and engine compartment fire.

    Product
    KIA — KIA OPTIMA, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V511000·2020-08-27

    RAM 3500, 4500, 5500 Recall for Engine Oil Film Defect

    Chrysler is recalling 2019-2020 RAM 3500, 4500, and 5500 cab chassis vehicles due to a defect that can cause engine damage and fire risk.

    Product
    RAM — RAM 3500, 5500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V510000·2020-08-27

    Vac-Tron Recalls 140 Trucks for Rear Extremity Safety Defect

    Vac-Tron is recalling 140 trucks because the rear extends too far, increasing injury risk in rear-end crashes.

    Product
    VAC-TRON — VAC-TRON HTV 373 PTO, JTV 873 PTO, HTV 873 PTO, HTV 573 PTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V518000·2020-08-27

    Kia Stinger recalled for engine compartment fire hazard

    Kia is recalling certain 2018-2021 Stinger vehicles due to risk of engine compartment fire in the antilock brake control unit. Owners should park outside and away from structures until the fuse kit replacement is completed.

    Product
    KIA — KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V520000·2020-08-27

    Hyundai Recalls Santa Fe Sport Vehicles Due to Brake Fluid Leak Risk

    Hyundai is recalling 2013-2015 Santa Fe Sport vehicles because brake fluid may leak inside the ABS module, creating a risk of engine compartment fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V512000·2020-08-27

    Dodge Charger Recall: Backup Camera Fails in Stealth Mode

    Chrysler is recalling 2018-2020 Dodge Charger Pursuit vehicles because the backup camera may not display in reverse when stealth mode is active, increasing crash risk.

    Product
    DODGE — DODGE CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20772·2020-08-27

    Amazon Recalls Wintergreen Essential Oil Due to Non-Child-Resistant Packaging

    Amazon is recalling Calmer Solutions Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    Calmer Solutions Wintergreen Gautheria Procumdens 100% Pure Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V513000·2020-08-27

    Ram 1500 Recall: Floormats May Interfere with Accelerator Pedal Return

    Chrysler is recalling 2019-2020 Ram 1500 trucks with adjustable pedals because floormats may prevent the accelerator from returning to the idle position, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E060000·2020-08-27

    Chrysler Recalls Mopar Floor Mat Kits for Ram 1500 Vehicles

    Chrysler is recalling Mopar All-Weather Floor Mat Kits for 2019-2020 Ram 1500 vehicles because the mats may interfere with the accelerator pedal, increasing crash risk.

    Product
    EQUIPMENT:ACCESSORY:FLOOR MAT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V516000·2020-08-27

    BMW Recalls 2019-2020 Z4 and 2020 Toyota Supra for Headlamp Defect

    BMW is recalling 4,265 vehicles because adjustable headlamps may violate federal safety standards, potentially causing glare or reduced visibility.

    Product
    BMW — BMW, TOYOTA Z4, SUPRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E061000·2020-08-27

    ZF Recalls Curtain Air Bag Inflators Due to Diffuser Separation Risk

    ZF North America is recalling specific curtain air bag inflators where improperly crimped diffusers may separate during deployment, potentially preventing proper air bag inflation.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V517000·2020-08-27

    Land Rover Recalls 2020 Range Rover Evoque for Tire Pressure Software Error

    Jaguar Land Rover is recalling 2020 Range Rover Evoque vehicles because incorrect tire pressure settings may prevent warning lights from illuminating, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20773·2020-08-27

    Amazon Recalls Birch Sweet Essential Oil Due to Packaging Safety Issue

    Amazon is recalling about 54 bottles of Mystic Moments Birch Sweet Essential Oil because the packaging is not child-resistant, posing a risk of poisoning.

    Product
    Birch Sweet Essential Oil 100% Pure
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V509000·2020-08-27

    Newmar Recalls Motorhomes Due to Instrument Panel Glare Risk

    Newmar is recalling specific 2018-2019 motorhomes because the instrument panel brightness cannot be adjusted, creating glare that may increase crash risk.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, ESSEX, VENTANA, DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20771·2020-08-27

    Morpher Flat-Folding Bicycle Helmets Recalled for Head Injury Risk

    CPSC warns consumers to stop using and dispose of Morpher flat-folding bicycle helmets because they do not meet federal safety standards, posing a risk of head injury.

    Product
    Morpher flat-folding bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V508000·2020-08-27

    Vac-Tron Recalls 134 Vehicles for Missing Clearance Lamps and Reflectors

    Vac-Tron is recalling 134 agricultural vehicles from 2015-2020 because they lack required side and rear clearance lamps and reflectors, which may make them harder to see.

    Product
    VAC-TRON — VAC-TRON HTV 573 PTO, HTV 873 PTO, HTV 373 PTO, JTV 873 PTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·20V514000·2020-08-27

    2021 BMW X7 Recalled for Incorrect Tire Information Labels

    BMW is recalling 2021 X7 models for tire information labels with incorrect specifications. The labels may not match the actually installed tires, potentially causing drivers to select wrong tires.

    Product
    BMW — BMW X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1504-2020·2020-08-26

    Ferring Recalls DDAVP Nasal Spray Due to Superpotent Drug Risk

    Ferring Pharmaceuticals is recalling 15,175 bottles of DDAVP Nasal Spray because the drug may be superpotent. The recall is voluntary and nationwide.

    Product
    DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1276-2020·2020-08-26

    Kroger Recalls Murray's Chads Smoked Gouda Dip for Salmonella Risk

    The Kroger Co is recalling Murray's Chads Smoked Gouda Dip due to potential contamination with Salmonella Newport. Consumers should check sell-by dates and discard the product.

    Product
    MURRAY'S CHADS SMOKED GOUDA DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Food)·F-1286-2020·2020-08-26

    Kroger Recalls Jarlsberg Dip Tubs Due to Salmonella Newport Risk

    The Kroger Co is recalling Jarlsberg Dip in plastic tubs due to potential contamination with Salmonella Newport. Consumers should check sell-by dates and discard or return the product.

    Product
    JARLSBERG DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Food)·F-1167-2020·2020-08-26

    Haven's Kitchen Golden Turmeric Tahini Recalled for Undeclared Soy

    Haven's Kitchen is recalling Golden Turmeric Tahini because the product is labeled as the wrong sauce, resulting in soy being undeclared on the label.

    Product
    HAVEN'S KITCHEN***GOLDEN TURMERIC TAHINI***NET WT 5oz (142g)***Ingredients: Water, Tahini, Extra Virgin Olive Oil, Roasted Garlic, Lemon Juice Concentrate, Date Paste, Sea Salt, Turmeric, Cumin, Ground Sumac (Sumac, Salt), White Pepper***
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Drugs)·D-1509-2020·2020-08-26

    FDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility

    CareFusion 213, LLC is recalling 12,500 units of Chloraprep One-Step applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-1278-2020·2020-08-26

    Kroger Recalls Murray's Bacon Chive Jarlsberg Dip Due to Salmonella Risk

    The Kroger Co is recalling Murray's Bacon Chive Jarlsberg Dip due to potential contamination with Salmonella Newport. The product was distributed in 20 states.

    Product
    MURRAY'S BACON CHIVE JARLSBERG DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Food)·F-1292-2020·2020-08-26

    Kroger Recalls Jarlsberg Dip Tubs Due to Salmonella Newport Contamination

    The Kroger Co is recalling Jarlsberg Dip in plastic tubs due to potential contamination with Salmonella Newport. Consumers should check sell-by dates and return the product.

    Product
    JARLSBERG DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Food)·F-1288-2020·2020-08-26

    Kroger Deli Applewood Cheddar Dip Recalled for Salmonella Newport Risk

    The Kroger Co is recalling Deli Applewood Cheddar Dip due to potential contamination with Salmonella Newport. Consumers should check sell-by dates and discard the product.

    Product
    DELI APPLEWOOD CHEDDAR DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Drugs)·D-1511-2020·2020-08-26

    CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

    Product
    ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1506-2020·2020-08-26

    Ferring Recalls STIMATE Nasal Spray Due to Superpotent Drug Risk

    Ferring Pharmaceuticals is recalling 29,371 vials of STIMATE nasal spray because the drug is superpotent. The recall is voluntary and nationwide.

    Product
    STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1290-2020·2020-08-26

    Kroger Recalls Deli Southwest Cheese Spread Kits Due to Salmonella Risk

    The Kroger Co is recalling Deli Southwest Cheese Spread Kits due to potential contamination with Salmonella Newport. Consumers should check their refrigerators and dispose of any affected products.

    Product
    DELI SOUTHWEST CHEESE SPREAD KIT in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Drugs)·D-1510-2020·2020-08-26

    CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

    CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1505-2020·2020-08-26

    Ferring Recalls Desmopressin Acetate Nasal Spray Due to Superpotency

    Ferring Pharmaceuticals is recalling 184,325 vials of Desmopressin Acetate Nasal Spray because the drug is superpotent. The recall is voluntary and nationwide.

    Product
    Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1160-2020·2020-08-26

    Earth Grown Mocha Fudge Frozen Dessert Recalled for Undeclared Cashews

    Smith Foods Inc. is recalling Earth Grown Mocha Fudge Non-Dairy Frozen Dessert due to undeclared cashews, a major food allergen.

    Product
    Earth Grown brand Mocha Fudge Non-Dairy Frozen Dessert in pint sized paperboard carton with a paperboard lid.
    Category
    Food
    Distribution
    36 states
  • SevereFDA (Food)·F-1291-2020·2020-08-26

    Kroger Deli Ranch Cheese Spread Kit Recalled for Salmonella Risk

    The Kroger Co is recalling Deli Ranch Cheese Spread Kits due to potential contamination with Salmonella Newport. The products were distributed in 20 states.

    Product
    DELI RANCH CHEESE SPREAD KIT in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1280-2020·2020-08-26

    Kroger Recalls AFIN Jarlsberg Cheese Spread Kits for Salmonella Risk

    The Kroger Co is recalling AFIN Jarlsberg Cheese Spread Kits due to potential contamination with Salmonella Newport. The products were distributed in 20 states.

    Product
    AFIN JARLSBERG CHEESE SPREAD KIT in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1282-2020·2020-08-26

    Kroger Recalls Deli Jarlsberg Jalapeno Dip for Salmonella Risk

    The Kroger Co is recalling Deli Jarlsberg Jalapeno Dip in plastic tubs due to potential contamination with Salmonella Newport.

    Product
    DELI JARLSBERG JALAPENO DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-1289-2020·2020-08-26

    Kroger Deli Buffalo Blue Cheese Spread Kit Recalled for Salmonella Risk

    The Kroger Co is recalling Deli Buffalo Blue Cheese Spread Kits due to potential contamination with Salmonella Newport. The product was distributed in 20 states.

    Product
    DELI BUFFALO BLUE CHEESE SPREAD KIT in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2821-2020·2020-08-26

    Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables

    Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.

    Product
    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1508-2020·2020-08-26

    Lannett Recalls Prednisone Tablets Due to Labeling Error

    Lannett Company, Inc. is recalling specific batches of Prednisone Tablets due to a labeling error where 2.5 mg bottles contained 10 mg tablets.

    Product
    Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 052
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·20172·2020-08-26

    CMP Group Recalls Dock Ladders Due to Sharp Edge Laceration Hazard

    CMP Group is recalling aluminum dock ladders because sharp edges on the steps can cut consumers. About 750 units were sold online from 2017 to 2020.

    Product
    Standoff and Wide Dock Ladders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1253-2020·2020-08-26

    Woodstock Farms Southwest Tex-Mex Trail Mix Recalled for Undeclared Wheat

    United Natural Trading Inc. is recalling Price Chopper Southwest Tex-Mex Trail Mix because the packaging incorrectly labels the product, failing to declare wheat.

    Product
    Price Chopper, Southwest Tex-Mex Trail Mix, 12 oz. re-closeable bag, 6 packages per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2828-2020·2020-08-26

    NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling

    Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.

    Product
    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V505000·2020-08-26

    2020 Audi SQ5 and Volkswagen vehicles recalled for defective seat welds

    Certain 2020 Audi SQ5 and Q5 vehicles and 2020-2021 Volkswagen models have improperly welded front seat frames. In a rear-end crash, the defective welds could fail and reduce occupant restraint, increasing the risk of injury.

    Product
    AUDI — AUDI, VOLKSWAGEN Q5, SQ5, ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1159-2020·2020-08-26

    High Liner Foods Recalls Crab Cakes Due to Undeclared Soy Protein

    High Liner Foods is recalling frozen Maryland-style crab cakes because they contain undeclared hydrolyzed soy protein.

    Product
    HIGH LINER FOODSERVICE***Genuine Maryland-Style Premium Crab Cakes***48-3 oz***KEEP FROZEN***10004302***PRODUCT OF CHINA***DISTRIBUTED BY: HIGH LINER FOODS< PORTSMOUTH, NY 03801; packaged in 9 lb bulk food service cases
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-1283-2020·2020-08-26

    Kroger Deli Bacon Chive Jarlsberg Dip Recalled for Salmonella Risk

    The Kroger Co is recalling Deli Bacon Chive Jarlsberg Dip due to potential contamination with Salmonella Newport. Consumers should check sell-by dates and discard the product.

    Product
    DELI BACON CHIVE JARLSBERG DIP in plastic tubs, all sizes.
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1161-2020·2020-08-26

    Earth Grown Chocolate Non-Dairy Frozen Dessert Recalled for Undeclared Cashews

    Smith Foods Inc. is recalling Earth Grown brand Chocolate Non-Dairy Frozen Dessert because it contains undeclared cashews, a major food allergen.

    Product
    Earth Grown brand Chocolate Non-Dairy Frozen Dessert in pint sized paperboard carton with a paperboard lid.
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-2807-2020·2020-08-26

    Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues

    Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1165-2020·2020-08-26

    Pineapple Yogurt Recalled for Undeclared Coconut Flakes

    Upstate Niagara Cooperative is recalling Wegmans Pineapple Lowfat Yogurt because it may contain undeclared coconut flakes, a potential allergen.

    Product
    "Wegmans***Food you Feel Good About*** Fruit on the Bottom***LOWFAT YOGURT*** PINEAPPLE ***6oz(170g)"
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1254-2020·2020-08-26

    Nature's Path Gluten-Free Cereal Recalled for Undeclared Wheat and Barley

    Nature's Path is recalling Gluten-Free Organic Mesa Sunrise Cereal because it contains undeclared wheat and/or barley, posing a risk to individuals with celiac disease or gluten sensitivity.

    Product
    Gluten-Free Organic Mesa Sunrise Cereal USA, Nature's Path brand. Shop Order # 127895. Product is Ready to eat breakfast cereal and shelf stable. Packaged in poly film bag. Each bag has a net Wt. 26.4 oz., each case has 6 bags. Case UPC: 0 58449 77901 8. The label is read
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2805-2020·2020-08-26

    PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery

    Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.

    Product
    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2020·2020-08-26

    Golden Technologies Lift Chair Recalled for Suspected Poor Weld

    Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.

    Product
    Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·20V504000·2020-08-26

    Volkswagen headlights recalled for misalignment defect in 2020-2021 Atlas models

    Volkswagen is recalling 2020 and 2021 Atlas vehicles due to driver's side headlights that may have been aimed too low during production. This misalignment fails to meet federal safety standards and reduces driver visibility.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1168-2020·2020-08-26

    Lund's and Byerly's Sea Salt Caramels Recalled for Undeclared Almonds

    Abdallah Candies is recalling Lund's and Byerly's Sea Salt Caramels because the boxes may contain undeclared almonds, posing a risk to individuals with allergies.

    Product
    Lund's and Byerly's Sea Salt Caramels, Net wt 16 oz (454 g), UPC 72431-00489
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2816-2020·2020-08-26

    DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues

    Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.

    Product
    DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V506000·2020-08-26

    Kenworth and Peterbilt trucks recalled for suspension bolt defects

    PACCAR is recalling approximately 1,097 certain 2020-2021 Kenworth and Peterbilt heavy trucks with Watson and Chalin steerable lift axle suspension systems. The pivot bolts may be too short to properly engage the locking nuts, risking separation from the suspension and potential vehicle crashes.

    Product
    KENWORTH — KENWORTH, PETERBILT W900, 567, 365, 367
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1158-2020·2020-08-26

    He Butt Recalls Blue Cheese Salmon Burgers for Undeclared Wheat

    He Butt is recalling specific blue cheese salmon burgers sold in Texas due to undeclared wheat. The recall was initiated voluntarily by the firm.

    Product
    Salmon, Burger Atlantic Blue Cheese Net Weight 12 oz (340g) UPC 23725500000; HEB Meal Simple Blue Cheese Salmon Burger NET WT 12 oz. (340g) UPC 23757500000; HEB Meal Simple Blue Cheese Wild Salmon Burgers NET WT 12oz (340g) UPC 23759000000; Salmon, Burger Atlantic Blue Cheese
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2818-2020·2020-08-26

    Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment

    Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.

    Product
    Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-1529-2020·2020-08-26

    Calvin Scott Recalls Phentermine Capsules Due to Packaging Defect

    Calvin Scott & Co. is recalling Phentermine HCL capsules because light-sensitive products were repackaged in transparent pouches.

    Product
    Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2829-2020·2020-08-26

    Cytocell NUP98 Distal Probe Green Recalled for False Positive Risk

    Cytocell Ltd. is recalling NUP98 Distal Probe Green units due to a low risk of false positive results in laboratory testing.

    Product
    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the vis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1526-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defects

    Calvin Scott & Company is recalling specific lots of Phentermine HCL capsules because light-sensitive products were repackaged in transparent pouches.

    Product
    Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1516-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Hydrochlorothiazide 50mg tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1519-2020·2020-08-26

    Calvin Scott Recalls Thyroid Neutral Tabs Due to Packaging Deviation

    Calvin Scott & Company is recalling Thyroid Neutral Tabs 2 gr because light-sensitive tablets were repackaged in transparent pouches, violating CGMP standards.

    Product
    Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1532-2020·2020-08-26

    Calvin Scott Recalls Phentermine Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling specific lots of Phentermine HCL 37.5 mg tablets because they were repackaged in transparent pouches, violating light-sensitivity requirements.

    Product
    Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1520-2020·2020-08-26

    Calvin Scott Recalls Topiramate 25mg Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Topiramate 25mg tablets because light-sensitive drugs were repackaged in transparent pouches, violating CGMP standards.

    Product
    Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2806-2020·2020-08-26

    Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets

    Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.

    Product
    ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2020·2020-08-26

    CareFusion Alaris PCA Module 8120 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris PCA Module Model 8120 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2826-2020·2020-08-26

    CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1527-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defects

    Calvin Scott & Company is recalling Phentermine HCL 30mg capsules because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1521-2020·2020-08-26

    Calvin Scott Recalls Phendimetrazine Tablets Due to Packaging Defects

    Calvin Scott & Company is recalling specific lots of Phendimetrazine 35mg tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

    Product
    Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2020·2020-08-26

    Calvin Scott Recalls Thyroid 1 Grain Tablets Due to Packaging Defects

    Calvin Scott & Co. is recalling specific lots of Thyroid 1 Grain Tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1522-2020·2020-08-26

    Calvin Scott Recalls Phendimetrazine Tablets Due to Packaging Deviation

    Calvin Scott & Company is recalling specific lots of Phendimetrazine 35mg tablets because light-sensitive products were repackaged in transparent pouches.

    Product
    Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2814-2020·2020-08-26

    Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton

    Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.

    Product
    Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2810-2020·2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for sy
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2822-2020·2020-08-26

    CareFusion Alaris Pump Module 8100 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2809-2020·2020-08-26

    Chembio DPP Micro Reader II Recalled for Performance Issues

    Chembio Diagnostics is recalling 97 DPP Micro Reader II kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2827-2020·2020-08-26

    Smith & Nephew Recalls Polarstem Collar Reamer Guides Due to Design Issue

    Smith & Nephew is recalling 528 units of the Polarstem Collar Reamer Guide due to a product design issue. The devices were distributed worldwide and in the US.

    Product
    POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2813-2020·2020-08-26

    Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices

    Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.

    Product
    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1528-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defect

    Calvin Scott & Company is recalling Phentermine HCL 30mg capsules because they were repackaged in transparent pouches, exposing the light-sensitive medication to potential degradation.

    Product
    Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2825-2020·2020-08-26

    CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2020·2020-08-26

    Chembio DPP Micro Reader Recalled for Performance Issues

    Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1514-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Hydrochlorothiazide 25mg tablets because light-sensitive products were repackaged in transparent pouches.

    Product
    Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2823-2020·2020-08-26

    CareFusion Alaris Syringe Module LED Display Dimness Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because the LED display may show dim segments, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2830-2020·2020-08-26

    Pharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads

    Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads because the device was incorrectly registered as a Class I device and requires a 510(k) submission.

    Product
    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location du
    Category
    Medical Device
    Distribution
    Distributed nationwide

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