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Medical Devices

Updated: May 12, 2023 4:00 PM

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

11 months ago •source www.fda.gov

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 #us

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

1 year ago •source www.fda.gov

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 #us

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

1 year ago •source www.fda.gov

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 #us

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

1 year ago •source www.fda.gov

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

#blood #recall #medicaldevices #us #pita

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

1 year ago •reported by user-hhkgt152

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 #ca #sub #ro-tel

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Fabuloso, Norton, OH, USA

1 year ago •reported by user-qvbpk985

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 #us

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

1 year ago •source www.fda.gov

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 #us

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

1 year ago •source www.fda.gov

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 #us #lays

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

1 year ago •source www.fda.gov

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 #us #bacterial #cream #sourcream

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Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA

1 year ago •source www.fda.gov

Recall notice

Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, their molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, … See More

#coronaviruscovid19 #medicaldevices #recall #us

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Medical Devices

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

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

Detect, Inc. Over the counter Covid-19 Test - recalled due to may give false negative results, USA

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