DrugSep 30, 2020
GRUPO YACANA MEXICO SAS DE CV Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz recall — FDA D-1590-2020
cGMP Deviations
Class IIFDA: TerminatedGRUPO YACANA MEXICO SAS DE CV
September 2020 recalls — page 3
These records include useful source details for the selected month.
DrugSep 30, 2020
Preferred Pharmaceuticals Nature-Throid, 1/2 Grain, 32.5 mg recall — FDA D-1621-2020
CGMP Deviations
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
DrugSep 30, 2020
Preferred Pharmaceuticals Nature-Throid, 1 Grain, 65 mg recall — FDA D-1623-2020
CGMP Deviations
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
VehicleSep 30, 2020
Model Y exterior lighting recall — NHTSA campaign 20V609000
Tesla, Inc. (Tesla) is recalling certain 2020 Model Y vehicles equipped with a global rear lamp and tow package configuration. A software error prevents the illumination of trailer brake…
exterior lightingTesla, Inc.
VehicleSep 30, 2020
BMW camera recall — NHTSA campaign 20V598000
BMW of North America, LLC (BMW) is recalling certain 2020-2021 X3 sDrive 30i, X3 xDrive 30i, X3M 40i, X3 xDrive 30e, X4 xDrive 30i, X4M 40i, 530i, 540i, 540i xDrive, M550i xDrive, M5, 550e,…
cameraBMW of North America, LLC
VehicleSep 30, 2020
BMW traction battery recall — NHTSA campaign 20V601000
BMW of North America, LLC (BMW) is recalling certain 2020-2021 530e, 530e xDrive, 530e iPerformance and X3 xDrive30e and MINI Cooper Countryman All4 SE, 2020 BMW i8, and 2021 330e, 330e…
traction batteryBMW of North America, LLC
VehicleSep 24, 2020
General Motors service brakes recall — NHTSA campaign 20V588000
General Motors LLC (GM) is recalling certain 2020 Chevrolet Corvette and Cadillac CT4, CT5 and XT4, 2021 Chevrolet Trailblazer, and 2020-2021 Buick Encore GX vehicles. Sensor connection…
service brakesGeneral Motors LLC
VehicleSep 24, 2020
Chrysler seat belts recall — NHTSA campaign 20V580000
Chrysler (FCA US LLC) is recalling certain 2019 Jeep Wrangler and Ram 2500, 2019-2020 Ram 1500 and 2020 Jeep Gladiator vehicles. In the event of a crash, a front seat belt retractor may not…
seat beltsChrysler (FCA US LLC)
Medical DeviceSep 23, 2020
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 recall — FDA Z-2971-2020
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Class IIFDA: TerminatedCook Inc.
Medical DeviceSep 23, 2020
Boston Scientific WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) recall — FDA Z-2958-2020
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceSep 23, 2020
RANDOX LABORATORIES AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in recall — FDA Z-2966-2020
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Class IIFDA: TerminatedRANDOX LABORATORIES, LTD.
Medical DeviceSep 23, 2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number recall — FDA Z-2960-2020
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceSep 23, 2020
Inpeco S.A FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) recall — FDA Z-2973-2020
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceSep 23, 2020
Roche Diagnostics Operations Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602 recall — FDA Z-2981-2020
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceSep 23, 2020
Oxford Immunotec Model No:T-SPOT.TB50, Catalogue No.: TB.50 recall — FDA Z-2977-2020
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Class IIIFDA: TerminatedOxford Immunotec
Medical DeviceSep 23, 2020
Life Technologies The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 recall — FDA Z-2978-2020
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false…
Class IIFDA: TerminatedLife Technologies Corporation
Medical DeviceSep 23, 2020
Oxford Immunotec Model No:T-SPOT.TB8, Catalogue No.: TB.300 recall — FDA Z-2976-2020
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Class IIIFDA: TerminatedOxford Immunotec
Medical DeviceSep 23, 2020
RANDOX LABORATORIES AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in recall — FDA Z-2965-2020
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Class IIFDA: TerminatedRANDOX LABORATORIES, LTD.
Medical DeviceSep 23, 2020
Novarad NovaPACS Diagnostic Viewer recall — FDA Z-2956-2020
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the…
Class IIFDA: TerminatedNovarad Corporation
Medical DeviceSep 23, 2020
LONGHORN VACCINES AND DIAGNOSTIC PrimeStore Molecular Transport Medium (PS-MTM), Model recall — FDA Z-2952-2020
The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on…
Class IIFDA: OngoingLONGHORN VACCINES AND DIAGNOSTIC
Medical DeviceSep 23, 2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 recall — FDA Z-2959-2020
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceSep 23, 2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting recall — FDA Z-2955-2020
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceSep 23, 2020
Medtronic The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients recall — FDA Z-2980-2020
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceSep 23, 2020
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of recall — FDA Z-2970-2020
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics 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.