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Safety Reports: Medical Devices

Updated: August 4, 2023 3:00 PM

Real Time Reports

Dräger Carina Sub-Acute Care Ventilators - recalled due to Product Safety/Potential Foreign Material, USA

1 year ago •source fda.gov • details

Recall notice

Drägerwerk AG & Co. KGaA initiated a voluntary recall notification for Dräger Carina Sub- Acute Care Ventilators to address possible contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. To date, Dräger’s market surveillance activities show that no… See more

#medicaldevices #recall #unitedstates

Dräger Carina Sub-Acute Care Ventilators - recalled due to Product Safety/Potential Foreign Material photo #1

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SIGMA Spectrum and Spectrum IQ Infusion pumps - Urgent Medical Device Correction due to false upstream occlusion alarms, USA

1 year ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that have been upgraded to software versions v8.01.01 and v9.02.01. The Correction is due to an increase in reported false… See more

#medicaldevices #recall #unitedstates

SIGMA Spectrum and Spectrum IQ Infusion pumps - Urgent Medical Device Correction due to false upstream occlusion alarms photo #1

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Walnut Wearable Smart Thermometer - recalled due to Potential for injuries, USA

2 years ago •source fda.gov • details

Recall notice

BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitoring of children ages 0-6 years which can… See more

#medicaldevices #recall #walmart #amazon #unitedstates

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Pilot COVID-19 At-Home Test - recalled due to Due to microbial contamination, USA

2 years ago •source fda.gov • details

Recall notice

SD Biosensor, Inc. is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected test kits were distributed by Roche Diagnostics… See more

#medicaldevices #recall #unitedstates

Pilot COVID-19 At-Home Test - recalled due to Due to microbial contamination photo #1

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Abbott FreeStyle Libre product family - Safety Notification due to battery swelling & overheating, USA

2 years ago •source fda.gov • details

Recall notice

Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader’s lithium-ion… See more

#medicaldevices #recall #unitedstates

Abbott FreeStyle Libre product family - Safety Notification due to battery swelling & overheating photo #1

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Life2000 Ventilation System - recalled due to patient oxygen desaturation, USA

2 years ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator.… See more

#medicaldevices #recall #blood #unitedstates #pita

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PRO Apixiban by Pro Doc, South Shore, QC, Canada

2 years ago • details

Was given a generic to Eliquis blood thinner called PRO Apixiban. The government will no longer cover Eliquis and it’s a life essential medication. But, sending billions overseas makes more sense.
One dose made me very ill for 22 days. It started with heart burn, gas, then… See more

#medicaldevices #blood #quebeccity #quebec #canada #sub #ro-tel

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Fabuloso, Norton, OH, USA

2 years ago • details

I have used fabuloso for years now I'm going to a infectious disease Dr I'm having problems with my throat

#medicaldevices #norton #ohio #unitedstates

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Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results, USA

2 years ago •source fda.gov • details

Recall notice

Universal Meditech Inc. initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by… See more

#medicaldevices #unitedstates

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results photo #1

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Smith’s Medical CADD Infusion System Infusion Sets for use with CADD pumps - recalled due to alarms issues, USA

2 years ago •source fda.gov • details

Recall notice

Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the… See more

#medicaldevices #recall #unitedstates #lays

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Safety Reports: Medical Devices

Real Time Reports

Dräger Carina Sub-Acute Care Ventilators - recalled due to Product Safety/Potential Foreign Material, USA

SIGMA Spectrum and Spectrum IQ Infusion pumps - Urgent Medical Device Correction due to false upstream occlusion alarms, USA

Walnut Wearable Smart Thermometer - recalled due to Potential for injuries, USA

Pilot COVID-19 At-Home Test - recalled due to Due to microbial contamination, USA

Abbott FreeStyle Libre product family - Safety Notification due to battery swelling & overheating, USA

Life2000 Ventilation System - recalled due to patient oxygen desaturation, USA

PRO Apixiban by Pro Doc, South Shore, QC, Canada

Fabuloso, Norton, OH, USA

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results, USA

Smith’s Medical CADD Infusion System Infusion Sets for use with CADD pumps - recalled due to alarms issues, USA

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