The Recall Desk

Archive

July 2020 recalls

590 recalls were announced in July 2020.

What the numbers show

Critical
11
Severe
159
High
329
Moderate
75
Low
16

Of the 590 recalls this month scored against our rubric, 2% are Critical, 27% are Severe.

Which agencies issued them

501–590 of 590

  • ModerateFDA (Devices)·Z-2478-2020·2020-07-08

    Ortho Organizers Recalls Mislabeled Maestro Orthodontic Brackets

    Ortho Organizers is recalling Maestro Orthodontic Brackets due to mislabeling. The recall involves 147 kits distributed to US and international consignees.

    Product
    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2465-2020·2020-07-08

    ROi CPS Recalls Isolation Droplet Bundle Kits Due to Labeling Error

    ROi CPS LLC is recalling 24 Isolation Droplet Bundle Kits because the kits are labeled with an expiration date later than the expiration date of the soonest component.

    Product
    Isolation Droplet Bundle Kit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1361-2020·2020-07-08

    Children's Robitussin DM Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling 132,336 bottles of Children's Robitussin DM because the included dosing cups lack age-specific measurement markings.

    Product
    CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM — CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2020·2020-07-08

    Ortho VITROS XT 7600 Software Recall for Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System software versions 3.5.1 and below because MicroWell Qualitative Assay parameters may reset to defaults.

    Product
    VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1376-2020·2020-07-08

    Flexion Recalls Zilretta Injectable Suspension Due to Temperature Abuse

    Flexion Therapeutics is recalling 792 kits of Zilretta (triamcinolone acetonide) because the product was stored at room temperature for more than six weeks.

    Product
    Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2020·2020-07-08

    Ortho VITROS 3600 System Recalled for Assay Parameter Reset Issue

    Ortho Clinical Diagnostics is recalling 27 refurbished VITROS 3600 Immunodiagnostic Systems because assay parameters may reset to defaults, potentially affecting test results.

    Product
    VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2486-2020·2020-07-08

    Ethicon Recalls Silk Sutures Due to Potential Shelf Life Deficiency

    Ethicon, Inc. is recalling specific lots of PERMA-HAND/MERSILK and VIRGIN SILK Blue twisted Silk Sutures because they may not meet the required 5-year shelf life.

    Product
    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1362-2020·2020-07-08

    Children's Dimetapp Cold & Cough Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling Children's Dimetapp Cold & Cough bottles because the included dosing cups are missing graduation marks for certain age groups.

    Product
    Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V396000·2020-07-07

    Chrysler and Dodge Vehicles Recalled for Steering Wheel Emblem Hazard

    Chrysler is recalling specific Town and Country, Grand Caravan, and Nitro models because a loose steering wheel emblem could become a projectile during air bag deployment.

    Product
    CHRYSLER — CHRYSLER, DODGE TOWN AND COUNTRY, NITRO, GRAND CARAVAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V398000·2020-07-07

    Keystone Recalls Fifth-Wheel Trailers Due to Antenna Separation Risk

    Keystone is recalling 2019-2020 fifth-wheel trailers because the television antenna may detach during transit, creating a road hazard.

    Product
    KEYSTONE — KEYSTONE RAPTOR, COUGAR, CARBON, FUZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E046000·2020-07-07

    Harbor Freight Recalls Pittsburg Automotive 3 Ton Heavy Duty Steel Jack Stands

    Harbor Freight is recalling 118,000 Pittsburg Automotive 3 Ton Heavy Duty Steel Jack Stands because the base seam weld may fail under load, causing the stand to drop suddenly.

    Product
    EQUIPMENT:MECHANICAL:INTEGRATED JACK/LEVELER/STABILIZER recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V395000·2020-07-06

    Mercedes-Benz Recalls AMG Models Due to Electronic Stability Control Software Error

    Mercedes-Benz is recalling 2019-2020 AMG models because incorrect Electronic Stability Program software may cause the system to react inaccurately, increasing the risk of a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC63 S, AMG GT63S, AMG GT63, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V392000·2020-07-02

    Gillig Recalls 2013-2020 Low Floor Buses Due to Steering Defect

    Gillig is recalling 2013-2020 Low Floor buses because a steering component may fail, causing a loss of power assist and increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V387000·2020-07-02

    Land Rover Recalls Range Rover Models Due to Door Latch Defect

    Land Rover is recalling 2013-2016 Range Rover and 2014-2016 Range Rover Sport vehicles because doors may be unlatched despite appearing closed, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V393000·2020-07-02

    Hyundai Recalls 2011-2012 Models for Accessory Socket Fire Risk

    Hyundai is recalling 272,126 vehicles because an over-tightened 12V accessory socket may overheat and cause a fire.

    Product
    HYUNDAI — HYUNDAI SONATA HYBRID, ELANTRA, ACCENT, VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V388000·2020-07-02

    Brake Hose Chafing in 2019-2021 Entegra Qwest and Jayco Motorhomes

    Jayco recalls 2019-2021 Entegra Qwest and Jayco Melbourne motorhomes because the front fender liner can chafe the brake hose, causing brake fluid loss and extended stopping distances.

    Product
    JAYCO — JAYCO, ENTEGRA MELBOURNE PRESTIGE, QWEST, MELBOURNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V391000·2020-07-02

    Airstream Recalls 2020-2021 Motorhomes Due to Suspension Bolt Defect

    Airstream is recalling 2020-2021 Atlas and Interstate motorhomes because suspension bolts may be too long, potentially breaking and affecting vehicle handling.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20758·2020-07-02

    Polaris Recalls Ranger and General Utility Vehicles Due to Crash Hazard

    Polaris is recalling approximately 26,730 Ranger and General utility vehicles because a software defect may cause sudden acceleration after a restart, posing a crash risk.

    Product
    Model Year 2019 - 2020 Ranger XP 1000 & Model Year 2020 General XP 1000 Utility Vehicles (UTVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V390000·2020-07-02

    2017-2021 Freightliner Cascadia brake modulator valve corrosion recall

    Certain 2017-2021 Freightliner Cascadia tractor trailers are recalled due to chemical corrosion in the brake modulator valve, which can slow brake release and cause brakes to pull to one side during automatic braking, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V389000·2020-07-02

    Kia Recalls 2015-2016 Soul EV for Parking Mechanism Software Defect

    Kia is recalling 2015-2016 Soul EVs because the parking mechanism may be damaged if the driver shifts to Park before the vehicle stops, potentially causing unintended movement.

    Product
    KIA — KIA SOUL EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V385000·2020-07-02

    Jayco Recalls 2017 North Point Fifth Wheels for Suspension Defect

    Jayco is recalling 2017 North Point fifth wheel trailers because leaf springs may fail to support loads, risking tire damage and loss of control.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL NORTH POINT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20757·2020-07-02

    Polaris Recalls Phoenix 200 ATVs Due to Throttle Crash Hazard

    Polaris is recalling 2018-2020 Phoenix 200 ATVs because a damaged throttle lever stop can cause a crash. No injuries have been reported.

    Product
    Model Year 2018-2020 Polaris Phoenix 200 ATVs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0999-2020·2020-07-01

    Radhuni Curry Powder Recalled for Salmonella Contamination

    New Hoque & Sons, Inc. is recalling Radhuni Curry Powder due to Salmonella contamination detected by FDA sampling.

    Product
    "Radhuni Curry Powder, 400 grams (14.11 oz.)***Ingredients: Coriander, Tumeric, Chili, Bitsalt, Aniseed, Sodium Chloride, Garlic, Cumin, Bay leaf, Ginger, Cinnamon, Clove, Cardamon***Product of Bangladesh***Imported by New Hoque & Sons Inc., NY USA***"
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1331-2020·2020-07-01

    Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected the impurity NDMA above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1329-2020·2020-07-01

    BIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials

    BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.

    Product
    Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1345-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling 192 bottles of Metformin Hydrochloride Extended-Release Tablets, 500 mg, due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1332-2020·2020-07-01

    Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1351-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, 500 mg, because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1352-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1000-2020·2020-07-01

    Rong Shing Trading Recalls Xi Zhi Liang Fruit Jelly Cups for Choking Hazard

    Rong Shing Trading NY Inc is recalling Xi Zhi Liang Fruit Jelly Cups due to a significant choking hazard. The product was distributed in five states.

    Product
    Xi Zhi Liang Fruit Jelly Cups; 21.1oz (600g); packaged in pink, yellow, and blue plastic backpacks with numerous individual plastic jelly cups inside each backpack and a toy car in a pouch on the front of the plastic backpack; the product contains konjac powder
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1347-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1344-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1353-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1393-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1356-2020·2020-07-01

    Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA

    Time-Cap Labs is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis found NDMA impurity above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2020·2020-07-01

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg because FDA analysis detected NDMA impurity above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·20V381000·2020-07-01

    Porsche Recalls 2020 911 Carrera 4S Coupe for Differential Bracket Issue

    Porsche is recalling 2020 911 Carrera 4S Coupe vehicles because the front axle differential bracket may not be tightened correctly, potentially causing damage to surrounding components and increasing fire risk.

    Product
    PORSCHE — PORSCHE 911 CARRERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1002-2020·2020-07-01

    NOW Real Food Raw Macadamia Nuts Recalled Due to Salmonella

    NOW Health Group is recalling 4,251 bags of Raw Macadamia Nuts because the product tested positive for Salmonella enterica.

    Product
    NOW Real Food Raw Macadamia Nuts Unsalted 8 oz retail bag UPC 733739071194 Item number 7119
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V380000·2020-07-01

    Forest River Recalls 2016 Amera-Lite Cargo Van Trailers for Drawbar Defect

    Forest River is recalling 2016 Amera-Lite Cargo Van trailers because insufficient drawbar steel thickness may cause fractures, leading to loss of control or detachment.

    Product
    AMERALITE — AMERALITE CARGO VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2020·2020-07-01

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1354-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1350-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2020·2020-07-01

    Merge Healthcare Software Recall for Inaccurate Z-Score Calculations

    Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.

    Product
    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2425-2020·2020-07-01

    Zest Anchors Recalls Locator Overdenture Implant Systems Due to Abutment Defects

    Zest Anchors LLC is recalling Locator Overdenture Implant Systems because the abutments may be out of specification, potentially causing a gap between the implant and abutment.

    Product
    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2020·2020-07-01

    Mevion Proton Radiation Treatment System Recalled for Software Error

    Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·20V382000·2020-07-01

    2020-2021 Forest River Vengeance Trailers Landing Leg Spacing Defect Recall

    Forest River is recalling certain 2020-2021 Vengeance trailers because the fifth-wheel landing legs are not properly spaced, potentially allowing the fifth wheel to slip and puncture the trailer floor, increasing injury risk.

    Product
    FOREST RIVER — FOREST RIVER VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2020·2020-07-01

    Siemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues

    Siemens is recalling Atellica Solution IM1600 Analyzers because insufficient sample volumes may not be detected when using specific sample cups.

    Product
    Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2404-2020·2020-07-01

    Siemens Atellica IM1300 Analyzer Recall for Insufficient Sample Detection Failure

    Siemens is recalling 927 Atellica Solution IM1300 Analyzers because they may fail to detect insufficient samples when using specific sample cups.

    Product
    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2428-2020·2020-07-01

    Providence Medical Technologies Recalls Ally Bone Screws Due to Dimensional Error

    Providence Medical Technologies is recalling 208 units of Ally Bone Screws due to a potential dimensional manufacturing error that poses a safety risk to patients.

    Product
    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2020·2020-07-01

    Tosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect

    Tosoh Bioscience Inc is recalling 529 AIA-900 Analyzers because the substrate monitoring system may fail to detect empty bottles, leading to erroneous immunoassay test results.

    Product
    AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1370-2020·2020-07-01

    Aurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence

    Aurobindo Pharma USA is recalling 1,440 bottles of Clozapine 100mg tablets because a consumer reported finding 50mg tablets in the 100mg bottles.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V384000·2020-07-01

    Volvo VNL and VNR Buses: Incorrect Axle Weight Rating Labels

    Volvo is recalling certain 2018–2021 VNL and VNR buses with incorrect Gross Axle Weight Rating labels on rear drive axles. Overloading could cause wheel hub failure and increase the risk of a crash.

    Product
    VOLVO — VOLVO VNR, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2020·2020-07-01

    Suntech Oscar 2 Blood Pressure Monitor Recall for Display Error

    Suntech Medical is recalling Oscar 2 blood pressure monitors because the display may show an incorrect decimal point for three-digit readings in mmHg.

    Product
    Oscar 2, Model 250 System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2020·2020-07-01

    GE Healthcare Recalls CARESCAPE Patient Data Modules Due to False Alarms

    GE Healthcare is recalling CARESCAPE Patient Data Modules because they may display false flat-line ECGs and asystole alarms when used with an AED.

    Product
    CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2418-2020·2020-07-01

    Hocoma Lokomat Pro Recalled for Uncontrolled Body Weight Support Rope Movement

    Hocoma AG is recalling 494 Lokomat Pro units because a motor controller failure may cause the body weight support rope to move up or down in an uncontrolled way.

    Product
    Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokoma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2020·2020-07-01

    Coltene Recalls Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Wingless Fiesta Kit forceps because a pin size defect may prevent them from fitting dental dam clamps.

    Product
    HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2421-2020·2020-07-01

    Coltene Recalls Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2420-2020·2020-07-01

    Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2020·2020-07-01

    Siemens ADVIA Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lots 534177 and 534179 due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    ADVIA Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2419-2020·2020-07-01

    Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2426-2020·2020-07-01

    RayStation Software Recalled for Treatment Record Import and Display Issues

    RaySearch Laboratories AB is recalling RayStation standalone software due to issues with treatment record imports and gantry angle display.

    Product
    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1341-2020·2020-07-01

    Alembic Recalls Aripiprazole Tablets Due to Labeling Error

    Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1335-2020·2020-07-01

    QuVa Pharma Recalls R.E.C.K. Syringes Due to Particulate Matter

    QuVa Pharma is recalling 17,050 syringes of R.E.C.K. solution because they may contain particulate matter. The product was distributed nationwide in the US.

    Product
    R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1338-2020·2020-07-01

    Crown Laboratories Recalls Subpotent Nystatin Cream Tubes

    Crown Laboratories is recalling 62,274 tubes of Nystatin Cream because the product failed potency testing at the 9-month interval.

    Product
    NYSTATIN CREAM — NYSTATIN CREAM (NYSTATIN CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1339-2020·2020-07-01

    Crown Laboratories Recalls Nystatin Cream for Subpotent Drug Levels

    Crown Laboratories is recalling Nystatin Cream, USP, because the product failed potency testing at the 9-month interval.

    Product
    NYSTATIN CREAM — NYSTATIN CREAM (NYSTATIN CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2427-2020·2020-07-01

    Argon Medical Devices Recalls BioPince Biopsy Instruments Due to Labeling Error

    Argon Medical Devices is recalling BioPince Full Core Biopsy Instruments because of incorrect product labeling. The recall affects 165 units in the U.S. and 330 units internationally.

    Product
    BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2020·2020-07-01

    Siemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors

    Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrators due to observed calibration errors in Total and Direct Bilirubin assays.

    Product
    Atellica CH Chemistry Calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1337-2020·2020-07-01

    Soft Whisper Dandruff Shampoo Recalled for Water Quality Deviations

    A.P. Deauville, LLC is recalling Soft Whisper Dandruff Shampoo because it was produced with water that failed USP specifications.

    Product
    Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2020·2020-07-01

    Siemens RP500e Handheld Barcode Scanner Recalled for Data Integrity Failure

    Siemens Healthcare Diagnostics Inc. is recalling 436 RP500e Handheld Barcode Scanners because they fail to verify Code 39 barcode data integrity using check-digits.

    Product
    RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1018-2020·2020-07-01

    Stumptown Cold Brew Coffee Recalled for Packaging Leakage

    Stumptown Coffee Corp is recalling 900 units of Cold Brew Coffee and Chocolate with Oatmilk due to packaging failure causing leakage.

    Product
    Stumptown Cold Brew Coffee and Chocolate with Oatmilk. Product is TetraPak Prisma Pak aseptic packaging. Keep refrigerated. Net 11 fl. oz (325 mL). UPC on the single unit is 8 55186 00688 5.
    Category
    Food
    Distribution
    8 states
  • LowFDA (Devices)·Z-2407-2020·2020-07-01

    Utak Trace Elements Serum Control Recalled for Incorrect Reference Values

    Utak Laboratories is recalling 1,395 vials of NR Trace Elements Serum Control due to incorrect cadmium reference values and expected ranges.

    Product
    Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1342-2020·2020-07-01

    Pfizer Recalls Duavee Tablets Due to Failed Dissolution Specifications

    Pfizer is recalling Duavee tablets because they failed to meet dissolution specifications. The recall covers 544,400 packages distributed nationwide.

    Product
    Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1372-2020·2020-07-01

    Nabumetone Tablets Recalled for Missing Medication Guide Labeling

    American Health Packaging is recalling 265 cartons of Nabumetone Tablets because the carton label did not include the required statement to dispense with the accompanying Medication Guide.

    Product
    Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
    Category
    Drug
    Distribution
    Distributed nationwide

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