The Recall Desk

Archive

March 2020 recalls

515 recalls were announced in March 2020.

What the numbers show

Critical
16
Severe
165
High
214
Moderate
96
Low
24

Of the 515 recalls this month scored against our rubric, 3% are Critical, 32% are Severe.

501–515 of 515

  • LowFDA (Drugs)·D-1063-2020·2020-03-04

    Breckenridge Recalls Zoledronic Acid Injection Due to Impurity Failures

    Breckenridge Pharmaceutical is recalling 900 vials of Zoledronic Acid Injection because stability testing revealed out-of-specification impurities.

    Product
    Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hun
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1391-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0856-2020·2020-03-04

    Golden State Medical Supply Recalls Tramadol Tablets Due to Labeling Error

    Golden State Medical Supply is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.

    Product
    TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2020·2020-03-04

    Akorn Recalls Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown particulate matter inside the tubes.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0781-2020·2020-03-04

    Nature's Sunshine NutriSmart Soy Powder Recalled for Unapproved Herbicide

    Pro-Form Manufacturing LLC is recalling Nature's Sunshine NutriSmart soy protein powder because the flax seed ingredient contains an unapproved herbicide.

    Product
    Nature's Sunshine NutriSmart Mezcla en polvo a base de proteina de soya enriquecida con vitaminas y minerals; Vainilla Plastic HDPE jar Contenido Neto 510 g UPC: 0 80030910217 Product number: 6116-GE3091 Elaborado por: Nature's Sunshine Products Inc. 1655 North Main Sp
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1389-2020·2020-03-04

    LivaNova SMART PERFUSION PACK INSPIRE 8S Recalled for Incorrect Cuvette Packaging

    LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.

    Product
    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1348-2020·2020-03-04

    Theralase TLC-2000 Laser Power Pack Recalled for Battery Testing Deficiency

    Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.

    Product
    TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1353-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V125000·2020-03-03

    Blue Bird Recalls School Buses Due to Seat Barrier Defect

    Blue Bird is recalling 2008-2021 Vision and All American school buses because the seat barrier behind the driver may be missing a reinforcing bracket, increasing injury risk in a crash.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION SCHOOL BUS, VISION TRANSIT BUS, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V126000·2020-03-03

    Thomas Built Buses Recall 2019-2020 Models for Brake Caliper Bolt Issue

    Daimler Trucks is recalling 581 Thomas Built school buses because loose brake caliper bolts may reduce braking effectiveness, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER HDX, SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V127000·2020-03-03

    Daimler Trucks Recalls 2019-2020 Vehicles for Brake Caliper Bolt Issue

    Daimler Trucks North America is recalling 2,585 2019-2020 trucks because brake caliper mounting bolts may be loose, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER, FCCC 4700, 5700, BUSINESS CLASS M2, XBR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V124000·2020-03-03

    Jeep Recalls Wrangler and Gladiator Vehicles for Clutch Fire Risk

    Chrysler is recalling 2018-2020 Jeep Wrangler and 2020 Gladiator vehicles with manual transmissions because the clutch pressure plate may overheat and fracture, increasing the risk of fire or crash.

    Product
    JEEP — JEEP WRANGLER, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20T005000·2020-03-03

    Tires Recalled for Sidewall Separation Defect

    Sentury Tire is recalling certain sidewall-tired models because a manufacturing defect causes the sidewall to separate, potentially leading to tire failure and increased crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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