DrugNov 10, 2021
Lupin Pharmaceuticals Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 recall — FDA D-0090-2022
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
November 2021 recalls — page 8
These records include useful source details for the selected month.
VehicleNov 10, 2021
Volkswagen Group of seats recall — NHTSA campaign 21V874000
Volkswagen Group of America, Inc. (Audi) is recalling certain 2017-2020 A4 Allroad, A4 Sedan, 2018-2019 RS5 Coupe, 2019 RS5 Sportback, 2018-2020 A5 Cabriolet, A5 Coupe, A5 Sportback, S4…
seatsVolkswagen Group of America, Inc.
VehicleNov 10, 2021
Ford traction battery recall — NHTSA campaign 21V869000
Ford Motor Company (Ford) is recalling one 2021 Escape vehicle equipped with a 2.5L hybrid powertrain. The high voltage battery may fail, resulting in a sudden loss of drive power.
traction batteryFord Motor Company
VehicleNov 10, 2021
Ford rear recall — NHTSA campaign 21V870000
Ford Motor Company (Ford) is recalling certain 2021 Explorer and Lincoln Aviator vehicles. Incorrect rear suspension module components may have been installed due to a labeling error.
rearFord Motor Company
VehicleNov 10, 2021
Chrysler air bag control module software recall — NHTSA campaign 21V873000
Chrysler (FCA US, LLC) is recalling certain 2021 Jeep Grand Cherokee L, 2022 Jeep Wagoneer, and Grand Wagoneer vehicles. The Occupant Restraint Controller (ORC) may have incorrect software…
air bag control module softwareChrysler (FCA US, LLC)
VehicleNov 10, 2021
Ram 1500 electrical heating element recall — NHTSA campaign 21V871000
Chrysler (FCA US, LLC) is recalling certain 2022 Ram 1500 vehicles. These vehicles may have been built with incompatible heating, ventilation, and air conditioning systems (HVAC), resulting…
electrical heating elementChrysler (FCA US, LLC)
VehicleNov 9, 2021
Tesla air bags recall — NHTSA campaign 21V868000
Tesla, Inc. (Tesla) is recalling certain 2021 Model X and Model S vehicles. The driver's air bag cushion may tear during deployment.
air bagsTesla, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm recall — FDA Z-0168-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm recall — FDA Z-0164-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm recall — FDA Z-0167-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
Xstrahl Concerto User Interface Software provided with the following systems: (1) Xstrahl recall — FDA Z-0174-2022
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during…
Class IIFDA: TerminatedXstrahl Limited
Medical DeviceNov 3, 2021
Smiths Medical ASD Bivona Uncuffed Wire Endotracheal Tubes recall — FDA Z-0178-2022
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceNov 3, 2021
Siemens Healthcare Diagnostics Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN recall — FDA Z-0180-2022
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm recall — FDA Z-0171-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
Elekta Oncentra Brachy users using version 4.0 and above with Applicator Modeling license recall — FDA Z-0182-2022
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Class IIFDA: OngoingElekta, Inc.
Medical DeviceNov 3, 2021
MEDTECH SAS ROSA One 3.1 Brain application The device is intended for the spatial recall — FDA Z-0118-2022
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global…
Class IFDA: OngoingMEDTECH SAS
Medical DeviceNov 3, 2021
AB SCIEX Cliquid MD version 3.4 software used in conjunction with Analyst MD software on recall — FDA Z-0175-2022
The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may…
Class IIFDA: TerminatedAB SCIEX
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm recall — FDA Z-0170-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm recall — FDA Z-0165-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
Siemens Healthcare Diagnostics Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) recall — FDA Z-0181-2022
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm recall — FDA Z-0169-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
Medical DeviceNov 3, 2021
CRHF C315-HIS Delivery Catheter recall — FDA Z-0173-2022
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Class IIFDA: OngoingMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medical DeviceNov 3, 2021
Becton Dickinson & Company BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf recall — FDA Z-0179-2022
Holes in product packaging impacts package integrity and may compromise sterility.
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceNov 3, 2021
W L Gore & Associates REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm recall — FDA Z-0166-2022
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Class IIFDA: OngoingW L Gore & Associates, Inc.
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.