Create a Report

Please provide report title

Please provide location

Make my report private

Please provide details

Alert regulators Alert business or product owner Get notifications for my case

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone

Phone Number

Please provide email or phone

Show my report on homepage

We do not show your email or contact info

Skip this step

I agree to Terms & Conditions

Please accept our Terms & Conditions

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone

Phone number

Please provide email or phone

I agree to Terms & Conditions

Please accept our Terms & Conditions

Report by

Message us

Safety Reports: Medical Devices

Updated: July 31, 2023 10:00 AM

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

#recall #medicaldevices #unitedstates

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

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

#amazon #walmart #recall #medicaldevices #unitedstates

Walnut Wearable Smart Thermometer - recalled due to Potential for injuries photo #1

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

#recall #medicaldevices #unitedstates

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

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

#recall #medicaldevices #unitedstates

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

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

#recall #blood #medicaldevices #unitedstates #pita

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

77

Helpful
Follow
Add my report
Share
- Copy link

Fabuloso, Norton, OH, USA

1 year 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

11

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

312

Helpful
Follow
Add my report
Share
- Copy link

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

1 year 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

#recall #medicaldevices #unitedstates

312

Helpful
Follow
Add my report
Share
- Copy link

After Burn® Cream and First Aid Kits containing After Burn Cream - recalled due to bacteria, USA

1 year ago •source fda.gov • details

Recall notice

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer… See more

#medicaldevices #unitedstates #bacterial #cream #sourcream