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Safety Reports: Medical Devices

Updated: September 22, 2023 4:02 PM

Real Time Reports

Recall notice

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect, USA

2 years ago •source fda.gov • details

On May 22, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities… See more

#ketogummiesscam #scam #medicaldevices #unitedstates

Recalls Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect On May 22, 2023, Uni... photo #1

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Recall notice

Universal Meditech Inc Test kits - recalled due to lacking premarket clearance, risking inaccurate test results, USA

2 years ago •source fda.gov • details

Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is because the company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed products, and 3 of the… See more

#ketogummiesscam #scam #recall #medicaldevices #unitedstates

Recalls Universal Meditech Inc Test kits - recalled due to lacking premarket clearance, risking inaccurate t... photo #1

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Recall notice

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

2 years ago •source fda.gov • details

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

#recall #medicaldevices #unitedstates

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

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Recall notice

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

2 years ago •source fda.gov • details

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

#recall #medicaldevices #unitedstates

Recalls SIGMA Spectrum and Spectrum IQ Infusion pumps - Urgent Medical Device Correction due to false upstre... photo #1

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Recall notice

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

2 years ago •source fda.gov • details

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

#walmart #amazon #recall #medicaldevices #unitedstates

Recalls Walnut Wearable Smart Thermometer - recalled due to Potential for injuries BearCare, Inc. is initiat... photo #1

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Recall notice

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

2 years ago •source fda.gov • details

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

#recall #medicaldevices #unitedstates

Recalls Pilot COVID-19 At-Home Test - recalled due to Due to microbial contamination SD Biosensor, Inc. is r... photo #1

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Recall notice

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

2 years ago •source fda.gov • details

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

#recall #medicaldevices #unitedstates

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

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Recall notice

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

2 years ago •source fda.gov • details

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

#blood #recall #medicaldevices #unitedstates #pita

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

2 years ago •reported by user-hhkgt152 • 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

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

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Fabuloso, Norton, OH, USA

2 years ago •reported by user-qvbpk985 • 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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Safety Reports: Medical Devices

Real Time Reports

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect, USA

Universal Meditech Inc Test kits - recalled due to lacking premarket clearance, risking inaccurate test results, USA

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

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