The Recall Desk

Archive

December 2020 recalls

500 recalls were announced in December 2020.

What the numbers show

Critical
15
Severe
129
High
252
Moderate
97
Low
7

Of the 500 recalls this month scored against our rubric, 3% are Critical, 26% are Severe.

Which agencies issued them

301–400 of 500

  • HighFDA (Devices)·Z-0537-2021·2020-12-16

    Chromsystems MassChrom Amino Acid Analysis Plasma Control Level I Recalled

    Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits because they do not meet stability criteria and may impact results.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2021·2020-12-16

    Randox Rx Series Mg Magnesium Test Kits Recalled for Performance Failure

    Randox Laboratories is recalling four kits of the Rx Series Mg Magnesium test due to reduced linearity performance.

    Product
    Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2021·2020-12-16

    Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

    Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

    Product
    Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2021·2020-12-16

    Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

    Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

    Product
    Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0155-2021·2020-12-16

    Chef Myron's Szechuan Sauce Recalled for Gluten-Free Mislabeling

    JMH International is recalling Chef Myron's Szechuan Sauce because it contains wheat-derived fermented soy sauce despite a gluten-free claim.

    Product
    Chef Myron's Szechuan Sauce, 64 FL OZ (1.89 L), Item # 400023293, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0163-2021·2020-12-16

    Pacific Coast Producers Recalls Tomato Paste Due to Metal Shavings

    Pacific Coast Producers is recalling 31,572 cases of 6-ounce tomato paste cans due to the presence of metal shavings. The product was distributed across the United States under multiple brand names.

    Product
    Tomato Paste in a 6 oz.(170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Happy Harvest, Kroger, Signature Select, Food Club, Members Mark, Great Value, Essential Everyday, Summer is Inside, Harmons, Pastene, Avenue A.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0558-2021·2020-12-16

    MANI Infusion Cannula 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling MANI Infusion Cannula 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or unintended disconnection during ophthalmic surgery.

    Product
    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2021·2020-12-16

    Clinical Innovations Recalls ROM Plus Collection Kits Due to Swab Defect

    Clinical Innovations is recalling ROM Plus Collection Kits because incorrect swabs may cause false test results.

    Product
    Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0557-2021·2020-12-16

    Mani Trocar Kit 23G S Recalled for Luer Connector Defects

    Mani, Inc. is recalling Trocar Kit 23G S units because Luer connector dimensions are out of specification, which may cause fluid leakage or disconnection during ophthalmic surgery.

    Product
    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V784000·2020-12-16

    Aston Martin Recalls 2021 DBX Vehicles for Missing Headliner Foam

    Aston Martin is recalling 151 2021 DBX vehicles because they were built without required headliner foam blocks, increasing injury risk in crashes.

    Product
    ASTON MARTIN — ASTON MARTIN DBX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0149-2021·2020-12-16

    Good & Gather Banana Chocolate Chip Date & Nut Bars Recalled for Undeclared Almonds

    Riverside Natural Foods is recalling Good & Gather Banana Chocolate Chip Date & Nut Bars because they contain undeclared almonds.

    Product
    Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 85239-04216 8. 5-1.6 oz (45g) Bars. Net Wt. 8oz (225g). DIST BY: Target Corporation, Minneapolis, MN 55403.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0166-2021·2020-12-16

    Kroger HomeChef Buffalo Pretzel Chicken Breast Meal Kit Recalled for Listeria Risk

    The Kroger Co is recalling 1,080 HomeChef meal kits because a supplier ingredient was suspect for Listeria species. No illnesses have been reported.

    Product
    HomeChef meal kit: Buffalo Pretzel Chicken Breast with Roasted Cauliflower and Broccoli. 29 ounce.
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0154-2021·2020-12-16

    Chef Myron's Teriyaki Sauce Recalled for Gluten-Free Mislabeling

    JMH International is recalling Chef Myron's Premium Teriyaki Sauce because it contains wheat-derived gluten despite a gluten-free claim.

    Product
    Chef Myron's Premium Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023118, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0165-2021·2020-12-16

    Kroger HomeChef Pretzel-Crusted Chicken Meal Kits Recalled for Listeria Risk

    Kroger is recalling HomeChef Pretzel-Crusted Chicken meal kits because a supplier ingredient was suspect for Listeria species.

    Product
    HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roasted broccoli and honey mustard..31.0 OZ (1 LB 15 OZ) 879g
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0159-2021·2020-12-16

    Chef Myron's Premium Shoyu Sauce Recalled for Gluten-Free Mislabeling

    JMH International is recalling Chef Myron's Premium Shoyu Sauce because it contains wheat-derived gluten despite a gluten-free claim.

    Product
    Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400023077, 2 bottles/case; 5 GAL (18.92 L), Item # 400023279, plastic pail
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·21052·2020-12-16

    Graco Recalls Inclined Sleeper Accessory for Four Playard Models

    Graco is recalling inclined sleeper accessories for four playard models due to a risk of infant suffocation. Consumers should stop using the accessory immediately and contact Graco for a refund.

    Product
    Inclined sleeper accessory included with the Graco Pack 'n Play Day2Dream Playard with Bedside Sleeper, Graco Pack 'n Play Nuzzle Nest Playard, Graco Pack 'n Play Everest Playard and Graco Pack 'n Play Rock 'n Grow Playard
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21053·2020-12-16

    Camp Chef Recalls Portable Gas Stoves Due to Fire Hazard

    Camp Chef is recalling about 20,600 portable gas stoves because a sharp edge on an internal gas regulator part can cause gas leaks, posing a fire hazard.

    Product
    Camp Chef portable stoves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2021·2020-12-16

    Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0164-2021·2020-12-16

    Pacific Coast Producers Recalls Italian Style Tomato Paste Due to Metal Shavings

    Pacific Coast Producers is recalling Italian Style Tomato Paste in 6 oz. cans due to the presence of metal shavings. The product was distributed under several grocery store brands.

    Product
    Italian Style Tomato Paste in a 6 oz. (170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Kroger, Signature Select, Harris Teeter, Food Club, Essential Everyday, Raleys, Fareway.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0157-2021·2020-12-16

    Chef Myron's Tsukeyaki Sauce Recalled for Gluten-Free Labeling Error

    JMH International is recalling Chef Myron's Tsukeyaki Sauce because it contains wheat-derived ingredients despite a gluten-free claim.

    Product
    Chef Myron's Tsukeyaki Sauce, 64 FL OZ (1.89 L), Item # 400023276, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2021·2020-12-16

    Canon CT Scanner Recall for Software Issue Causing Scan Failures

    Canon Medical System is recalling 60 Aquilion Prime SP CT scanners due to a software defect that may prevent automatic scans, requiring rescans and contrast reinjection.

    Product
    Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2021·2020-12-16

    Randox Mg R1 Magnesium Test Kit Recalled for Linearity Performance Failure

    Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.

    Product
    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0156-2021·2020-12-16

    Chef Myron's Tangy Teriyaki Sauce Recalled for Gluten Mislabeling

    JMH International is recalling Chef Myron's Tangy Teriyaki Sauce because it contains wheat-derived ingredients despite a gluten-free claim.

    Product
    Chef Myron's Tangy Teriyaki Sauce, 64 FL OZ (1.89 L), Item # 400023221, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0158-2021·2020-12-16

    Chef Myron's Yakitori Sauce Recalled for Gluten-Free Labeling Error

    JMH International is recalling Chef Myron's Yakitori Sauce because it contains wheat-derived ingredients despite a gluten-free claim.

    Product
    Chef Myron's Yakitori Sauce, 64 FL OZ (1.89 L), Item # 400023316, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0562-2021·2020-12-16

    BD Multi-Check CD4 Low Control Recalled for Inaccurate Flow Cytometry Results

    Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.

    Product
    BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0153-2021·2020-12-16

    Chef Myron's Ponzu Sauce Recalled for Gluten-Free Labeling Error

    JMH International is recalling Chef Myron's Ponzu Sauce because it contains wheat-derived ingredients despite a gluten-free claim.

    Product
    Chef Myron's Ponzu Sauce, 64 FL OZ (1.89 L), Item # 400023110, 4 bottles/case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2021·2020-12-16

    Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test results.

    Product
    3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0535-2021·2020-12-16

    LivaNova Recalls VNS Therapy SENTIVA DUO Generators Due to Model Number Error

    LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.

    Product
    VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0563-2021·2020-12-16

    Spacelabs Sentinel V10 and V11 Software Upgrade Recall

    Spacelabs Healthcare is recalling Sentinel V10.x and V11.x software because system upgrades may add or overwrite unrelated comments on existing ECG and ABP tests.

    Product
    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0116-2021·2020-12-16

    V-Klean Hand Sanitizer Gel Recalled for CGMP Violations

    Asiaticon, SA de CV is voluntarily recalling V-Klean Hand Sanitizer Gel Alcohol 70% due to a lack of Current Good Manufacturing Practices (CGMPs).

    Product
    V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0548-2021·2020-12-16

    Integra Recalls Mayfield A2000 Skull Cap Instruction Manual

    Integra LifeSciences Corp. is recalling 552 instruction manuals for the Mayfield A2000 Skull Cap to correct inaccurate illustrations.

    Product
    Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0152-2021·2020-12-16

    Chef Myron's Eurasian Fusion Sauce Recalled for Gluten Mislabeling

    JMH International is recalling Chef Myron's Eurasian Fusion Sauce because it contains wheat-derived fermented soy sauce despite a gluten-free claim.

    Product
    Chef Myron's Eurasian Fusion Sauce, 64 FL OZ (1.89 L), Item # 400023288, 4 bottles/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2021·2020-12-16

    Welch Allyn ELI 380 Electrocardiograph Recalled for Wireless Disconnection

    Welch Allyn is recalling 1,009 ELI 380 Electrocardiographs because the internal radio can disconnect from the wireless access point.

    Product
    ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0127-2021·2020-12-16

    Novocol Recalls Scandonest 3% Plain Due to Labeling Mix-Up

    Novocol Pharmaceutical is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. The product is distributed nationwide.

    Product
    SCANDONEST 3% PLAIN — SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V780000·2020-12-15

    Certain Jayco and Entegra Motorhomes Leveling System Support Bracket Defect Recall

    Jayco and Entegra are recalling certain 2020-2021 motorhomes with defective leveling system support brackets that may fail, allowing components to contact the ground and potentially leak hydraulic fluid, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO ESTEEM, GREYHAWK PRESTIGE, ODYSSEY, REDHAWK SE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V782000·2020-12-15

    2021 Volvo Truck Air Brake Line Defect Recall

    Volvo Trucks is recalling 6,982 commercial trucks (2021 VHD, VNL, VNR, and VAH models) because damaged collets in the air brake system may cause park brakes to apply unexpectedly, potentially causing loss of vehicle control.

    Product
    VOLVO — VOLVO VAH, VNL, VHD, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V779000·2020-12-15

    Rosenbauer Emergency Vehicles Recalled for LCD Display Lockup Defect

    Rosenbauer America is recalling specific emergency vehicles because LCD displays may lock up due to voltage spikes, potentially delaying emergency efforts.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER, AVENGER, WARRIOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V783000·2020-12-15

    AEV Ambulances Recalled for Potential LCD Display Malfunction

    Halcore is recalling specific 2020-2021 AEV ambulances because electrical spikes may cause the emergency lighting and HVAC control display to lock up or fail.

    Product
    AEV — AEV TYPE 1 F-SERIES AMBULANCE, TRAUMAHAWK, FREIGHTLINER M2 AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V781000·2020-12-15

    Ducati Scrambler motorcycles recalled due to electrical short-circuit fire risk

    Certain 2018-2021 Ducati Scrambler 1100 motorcycles may experience an electrical short-circuit when the exhaust valve cable contacts the positive battery wire, increasing fire risk. Dealers will install a new cable guide and cable tie at no charge.

    Product
    DUCATI — DUCATI SCRAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V772000·2020-12-11

    Mercedes-Benz Recalls One 2019 Sprinter 2500 for Hood Installation Defect

    Daimler Vans USA is recalling one 2019 Mercedes-Benz Sprinter 2500 because the engine hood may not have been installed properly, posing an injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E091000·2020-12-11

    Ohlins Recalls Front Struts for Porsche 911 Models Due to Pin Breakage Risk

    Ohlins is recalling front struts for specific Porsche 911 models because the strut pin may break during maximum steering, potentially causing loss of vehicle control.

    Product
    PORSCHE — PORSCHE 911 CARRERA, 911 TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V776000·2020-12-11

    Mercedes-Benz Recalls AMG GLC63 Vehicles Due to Starter Cable Defect

    Mercedes-Benz is recalling 2,563 AMG GLC63 vehicles because a starter cable may chafe and short-circuit, increasing the risk of a stall or fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V774000·2020-12-11

    Kawasaki Recalls 2021 Ninja 400 and Z400 Motorcycles for Engine Defect

    Kawasaki is recalling 2021 Ninja 400 and Z400 motorcycles because a weak camshaft chain tensioner could cause the engine to stall, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA 400, EX400G, Z400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V775000·2020-12-11

    Mercedes-Benz Recalls 2020 AMG GT Vehicles for Headlight Aim Defect

    Mercedes-Benz is recalling 2020 AMG GT vehicles because headlights may be aimed too high, reducing visibility of oncoming traffic and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V777000·2020-12-11

    Altec Recalls 2020 Aerial Devices Due to Boom Valve Defect

    Altec is recalling 2020 AN67-E100 aerial devices because a shuttle cartridge was installed instead of a plug, risking unintended boom movement and injury.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V767000·2020-12-10

    2020-2021 Forest River XLR Toy Hauler Weight Label Defect Recall

    Forest River is recalling certain 2020-2021 XLR Boost Toy Hauler recreational vehicles with inaccurate Federal Placards that may understate the vehicle's weight, risking tire damage and crashes from overloading.

    Product
    FOREST RIVER — FOREST RIVER XLR TOYHAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V765000·2020-12-10

    Altec Recalls 2018-2020 Digger Derricks Due to Hydraulic Valve Defect

    Altec is recalling 2018-2020 digger derricks and aerial devices because a hydraulic check valve snap ring can fail, causing unintended boom movement.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V769000·2020-12-10

    Honda Recalls 2013-2015 Accord Vehicles for Drive Shaft Defect

    Honda is recalling 2013-2015 Accord vehicles with 4-cylinder engines and CVTs in 23 states and D.C. because a lubricant issue may cause drive shafts to break, risking loss of power or vehicle roll-away.

    Product
    HONDA — HONDA ACCORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V770000·2020-12-10

    Honda and Acura Recall Vehicles for Potential Drive Shaft Breakage

    Honda is recalling specific 2007-2015 Acura and Honda models because improperly coated drive shafts may break, causing loss of power or vehicle roll-away.

    Product
    ACURA — ACURA, HONDA ILX, CIVIC HYBRID, FIT, ILX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21712·2020-12-10

    Scentsy Recalls Electrical Oil Warmers Due to Fire Hazard

    Scentsy is recalling Luminary Jack and Bless This Home electrical oil warmers because corrosion of electrical components poses a fire hazard.

    Product
    Scentsy Luminary Jack Warmer and Scentsy Bless This Home Warmer
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V766000·2020-12-10

    Subaru Recalls 2020 Outback and Legacy for Rearview Display Issues

    Subaru is recalling 2020 Outback and Legacy vehicles because a software update may cause the rearview display to shut off intermittently, increasing crash risk.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V771000·2020-12-10

    Honda Recalls Accord and Insight Vehicles for Software Error

    Honda is recalling 2018-2020 Accord and 2019-2020 Insight vehicles because a software error may cause system malfunctions that increase crash risk.

    Product
    HONDA — HONDA INSIGHT, ACCORD, ACCORD HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21713·2020-12-10

    Thermo Tents Recalls Mór Series Tents Due to Fire Hazard

    Thermo Tents is recalling Mór Series tents because they are incorrectly labeled as fire retardant, posing a fire hazard.

    Product
    Crua Tri, Crua Loj, and Crua Cottage tents in the Mór Series
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21714·2020-12-10

    Homfa Cabinets Recalled Due to Tip-Over and Entrapment Hazards

    Homfa HPB-087 and HPB-106 cabinets are recalled because they can tip over or entrap children if not anchored to the wall.

    Product
    Homfa HPB-087 and HPB-106 Cabinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0111-2021·2020-12-09

    Lohxa Recalls Chlorhexidine Gluconate Oral Rinse Due to Bacterial Contamination

    Lohxa LLC is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, due to contamination with Burkholderia lata bacteria.

    Product
    Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Food)·F-0144-2021·2020-12-09

    Dole Organic Romaine Hearts Recalled Due to E. coli Contamination

    Dole Fresh Vegetables Inc. is recalling specific lots of Organic Romaine Hearts because pathogenic non-O157 E. coli STEC was found during routine sampling.

    Product
    Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest Organic Romaine Hearts, Net Wt 12 oz. (UPC 7-11535-50201-2),
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Drugs)·D-0118-2021·2020-12-09

    MPM Medical Recalls REGENECARE HA Topical Anesthetic Due to Bacteria

    MPM Medical LLC is recalling REGENECARE HA topical anesthetic hydrogel because it was found to be contaminated with Burkholderia cepacia bacteria.

    Product
    REGENECARE HA — REGENECARE HA (LIDOCAINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0518-2021·2020-12-09

    Medtronic MiniMed 640G Insulin Pump Recalled for Missing Solder Battery Connection

    Medtronic is recalling MiniMed 640G insulin pumps because a missing solder battery connection could interrupt power. The recall covers specific serial numbers distributed in the U.S. and abroad.

    Product
    MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0145-2021·2020-12-09

    Tanimura & Antle Romaine Lettuce Recalled Due to E. coli O157:H7 Detection

    Tanimura & Antle is recalling specific lots of Romaine lettuce after Michigan state officials detected E. coli O157:H7 during routine sampling.

    Product
    Tanimura & Antle brand Romaine lettuce. 1 head 12,15,018 and 24 case Product of USA UPC: 2-27918 20314-9 Tanimura & Antle, Salinas, CA
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0514-2021·2020-12-09

    Invacare PerfectO2 V Oxygen Concentrator Recalled for Fire and Explosion Risk

    Invacare is recalling 384,767 PerfectO2 V oxygen concentrators worldwide due to a defect that may cause self-extinguishing fires or cap explosions.

    Product
    Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0526-2021·2020-12-09

    CME America Recalls NeoThrive Syringe Pumps Due to Motor Wear

    CME America is recalling 4,182 NeoThrive syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0527-2021·2020-12-09

    CME America T-Syringe Pump Recall for Motor Wear and Fluid Damage

    CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V760000·2020-12-09

    Audi Recalls 2018-2019 RS 5 Coupe for Battery Terminal Cover Defect

    Audi is recalling 2,355 2018-2019 RS 5 Coupe vehicles because an incorrect positive battery terminal cover could prevent doors from opening or hazard lights from working after a rear crash.

    Product
    AUDI — AUDI RS 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0516-2021·2020-12-09

    Medtronic MiniMed 670G Insulin Pumps Recalled for Battery Connection Defect

    Medtronic is recalling 391 MiniMed 670G insulin pumps because a missing solder battery connection could interrupt power to the device.

    Product
    MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·21046·2020-12-09

    L G Sourcing Recalls Electric Fireplaces Due to Fire Hazard

    L G Sourcing is recalling allen + roth 62-inch electric fireplaces sold at Lowe's because wiring connectors can overheat, posing a fire hazard.

    Product
    allen + roth 62-inch Electric Fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2021·2020-12-09

    Biomeme SARS-CoV-2 PCR Test Recalled for False Positive Results

    Biomeme is recalling 105 units of its SARS-CoV-2 Real-Time RT-PCR Test because the software made false positive calls due to assay issues.

    Product
    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0141-2021·2020-12-09

    Minute Maid Watermelon Fruit Drink Recalled for Metal Contamination

    The Coca-Cola Company is recalling Minute Maid Watermelon Flavored Fruit Drink after a consumer reported a long piece of metal in the product.

    Product
    Minute Maid WATERMELON FLAVORED FRUIT DRINK WITH OTHER NATURAL FLAVORS 59 FL OZ (1.8 QT) 1.75 L PRODUCED FOR THE COCA-COLA COMPANY ATLANTA, GA Unit UPC 0 25000 04811 1, Case UPC 000-25000-04812-8
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0504-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0148-2021·2020-12-09

    Tucson Tamale Blue Corn Veggie & Cheese Tamales Recalled for Plastic Contamination

    Tucson Tamale Wholesale Company is recalling specific lots of Blue Corn, Veggie & Cheese Tamales because plastic pieces were found in the tomato cans used to make them.

    Product
    Tucson Tamale Blue Corn, Veggie & Cheese Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00233, Keep Frozen, 6 packs/box (case)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0139-2021·2020-12-09

    Pacific Jade Curry Sauce Starter Recalled for Undeclared Anchovy

    Celtrade Canada is recalling Pacific Jade Indian Curry Sauce Starter because the inner product contains anchovy, which is not listed on the shipping case.

    Product
    Pacific Jade Indian Curry Sauce Starter With Fenugreek and Cardamom, wholesale case with 2, 39 oz. plastic tubs, case UPC 50758108742487
    Category
    Food
    Distribution
    1 state
  • HighCPSC·21044·2020-12-09

    Fiskars Recalls 16-Foot Pole Saws Due to Laceration Hazard

    Fiskars is recalling 16-foot extendable pole saws and pruners because the telescoping poles can separate and fall, posing a laceration hazard.

    Product
    Fiskars 16 foot Extendable Pole Saw/Pruners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21047·2020-12-09

    CRAFTSMAN 10-Inch Corded Chain Saws Recalled for Laceration Hazard

    Black & Decker is recalling CRAFTSMAN 10-inch corded chain saws with extension poles because they may start unexpectedly, posing a laceration risk.

    Product
    CRAFTSMAN® CMECSP610 10-inch corded chain saws with extension poles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21045·2020-12-09

    Burley Recalls Dash X FM Child Bicycle Seats Due to Crash Hazard

    Burley is recalling Dash X FM child bicycle seats because the reclining plate can detach, making the seat unstable and causing a crash hazard.

    Product
    Dash® X FM child bicycle seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0146-2021·2020-12-09

    Quantum Health Elderberry Liquid Extract Recalled for Salmonella Risk

    Quantum Inc. is recalling Quantum Health Elderberry liquid herbal extract due to potential Salmonella contamination. The product was distributed in Indiana, New Jersey, and New York.

    Product
    Quantum Health branded Elderberry liquid herbal extract dietary supplement is packaged in 2oz glass bottle, 12 bottles/case. Product is shelf stable with net wt. 2 fl oz/59 mL. UPC code: 0 46985 01625 4 Product is distributed by Quantum, Inc., Eugene, OR.
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·20V761000·2020-12-09

    2021 BMW vehicles recalled for defective 48-Volt battery connections

    BMW is recalling certain 2021 model vehicles due to improper assembly of the 48-Volt battery and starter-generator connection, which can increase electrical resistance and fire risk. Dealers will inspect and replace the connection if necessary.

    Product
    BMW — BMW X5, 530I, X6, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21042·2020-12-09

    Neptune Benson Recalls Delta UV Generators for Pools Due to Fire Hazard

    Neptune Benson is recalling Delta UV EA-4H-10 generators for pools and spas because water leaks can cause overheating and fire. No injuries have been reported.

    Product
    Delta UV EA-4H-10 ultra-violet generators installed in swimming pools and swim spas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasoun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning and disinfection instructions.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2021·2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Fluid Damage

    CME America is recalling 4,182 T-Syringe Pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2021·2020-12-09

    VEO Diagnostics Recalls ACCEL ELISA COVID-19 Antibody Test Kits

    VEO Diagnostics is recalling 15 ACCEL ELISA COVID-19 antibody test kits because the FDA removed their Emergency Use Authorization. Users should stop using the kits.

    Product
    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2021·2020-12-09

    K2M Recalls Yukon Anti-Torque Alignment Tubes Due to Manufacturing Defect

    K2M, Inc. is recalling four Yukon Anti-Torque Alignment Tubes from Lot KTGG because shafts do not pass through the inner cannula, potentially delaying surgery.

    Product
    Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0147-2021·2020-12-09

    Tucson Tamale Blue Corn and Veggie Tamales Recalled for Plastic Contamination

    Tucson Tamale Wholesale Company is recalling Blue Corn & Veggie Tamales because plastic pieces were found in the tomato cans used to make them.

    Product
    Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00234, Keep Frozen, 6 packs/box (case)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2021·2020-12-09

    CME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks

    CME America is recalling 4,182 T-Syringe Pump T34 units because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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