DrugDec 16, 2020
Shilpa Medicare Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only recall — FDA D-0126-2021
CGMP Deviations
Class IIFDA: TerminatedShilpa Medicare Limited
December 2020 recalls — page 10
These records include useful source details for the selected month.
DrugDec 16, 2020
Scandonest 3% Plain recall — FDA D-0127-2021
Labeling: Label mix-up
Class IIIFDA: TerminatedNovocol Pharmaceutical of Canada, Inc.
DrugDec 16, 2020
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only recall — FDA D-0122-2021
CGMP Deviations
Class IIFDA: TerminatedShilpa Medicare Limited
DrugDec 16, 2020
Asiaticon, SA de CV V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml) recall — FDA D-0116-2021
Lack of CGMPs:
Class IIFDA: TerminatedAsiaticon, SA de CV
VehicleDec 16, 2020
Audi Q3 pedals and linkages recall — NHTSA campaign 20V786000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2020 Audi Q3 vehicles. The brake pedal plate can bend or detach under the pressure applied during sudden stopping.
pedals and linkagesVolkswagen Group of America, Inc.
VehicleDec 10, 2020
Subaru of display function recall — NHTSA campaign 20V766000
Subaru of America, Inc. (Subaru) is recalling certain 2020 Legacy and Outback vehicles equipped with "high" grade and "mid" grade multimedia navigation. The August 2020 over-the-air…
display functionSubaru of America, Inc.
VehicleDec 10, 2020
Honda body control module software recall — NHTSA campaign 20V771000
Honda (American Honda Motor Co.) is recalling certain 2018-2020 Accord Sedan, Accord Hybrid, and 2019-2020 Insight vehicles. A software error may cause intermittent or continuous…
body control module softwareHonda (American Honda Motor Co.)
Medical DeviceDec 9, 2020
Olympus Ultrasound Endoscope recall — FDA Z-0504-2021
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceDec 9, 2020
Verathon BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for recall — FDA Z-0531-2021
Due to a change in handle material and process, probe handle may crack.
Class IIFDA: TerminatedVerathon, Inc.
Medical DeviceDec 9, 2020
Medtronic MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K recall — FDA Z-0517-2021
Missing solder battery connection, which could interrupt power of insulin pump.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceDec 9, 2020
VEO DIAGNOSTICS ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 recall — FDA Z-0510-2021
Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests
Class IIFDA: TerminatedVEO DIAGNOSTICS, LLC
Medical DeviceDec 9, 2020
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids recall — FDA Z-0525-2021
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
Class IIFDA: TerminatedCME America, LLC
Medical DeviceDec 9, 2020
CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids recall — FDA Z-0526-2021
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
Class IIFDA: TerminatedCME America, LLC
Medical DeviceDec 9, 2020
Olympus Ultrasound Endoscope recall — FDA Z-0499-2021
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceDec 9, 2020
Olympus Ultrasound Endoscope recall — FDA Z-0502-2021
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceDec 9, 2020
Covidien Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01 recall — FDA Z-0515-2021
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by…
Class IIFDA: OngoingCovidien LLC
Medical DeviceDec 9, 2020
Chromsystems Instruments & Chemicals GmbH MassChrom Cortisol, Cortisone Saliva Control Level recall — FDA Z-0522-2021
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Class IIFDA: CompletedChromsystems Instruments & Chemicals GmbH
Medical DeviceDec 9, 2020
Ethicon PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm recall — FDA Z-0533-2021
The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
Class IIFDA: TerminatedEthicon, Inc.
Medical DeviceDec 9, 2020
Becton Dickinson & Company BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for recall — FDA Z-0508-2021
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information…
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceDec 9, 2020
Medtronic MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only recall — FDA Z-0518-2021
Missing solder battery connection, which could interrupt power of insulin pump.
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceDec 9, 2020
Olympus Ultrasound Endoscope recall — FDA Z-0506-2021
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceDec 9, 2020
Bausch & Lomb Surgical MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic recall — FDA Z-0519-2021
Product may be missing toric axis marks.
Class IIFDA: TerminatedBausch & Lomb Surgical, Inc.
Medical DeviceDec 9, 2020
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders recall — FDA Z-0514-2021
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in…
Class IIFDA: TerminatedInvacare Corporation
Medical DeviceDec 9, 2020
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of recall — FDA Z-0529-2021
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be…
Class IIFDA: TerminatedCME America, LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.