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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP - due to Lack of sterility assurance, USA

2 years ago •source fda.gov • details

Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. The product was distributed in the United States and Canada. To… See more

#recall #medicaldevices #unitedstates

Recalls Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP - due to Lack of sterility assur... photo #1
312   Comments Comment

Recall notice

Medtronic McGRATH MAC video laryngoscopes - sale of Defective Products, USA

2 years ago •source fda.gov • details

On September 28, 2023, Medtronic issued this notification to inform the public of stolen defective McGRATH™ MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. These affected products did not pass Medtronic's rigorous quality tests established for… See more

#medicaldevices #unitedstates

Recalls Medtronic McGRATH MAC video laryngoscopes - sale of Defective Products On September 28, 2023, Medtro... photo #1
312   Comments Comment

Recall notice

Family Dollar Over-the-Counter Drug & Medical Device products - recalled due to improper storage temperature, USA

2 years ago •source fda.gov • details

Family Dollar is initiating a voluntary retail-level product recall of certain over-the-counter drugs and medical devices regulated by the U.S. Food and Drug Administration (FDA). These items were stored outside of labeled temperature requirements by Family Dollar and inadvertently shipped to certain stores on or around June… See more

#medicaldevices #drugs #recall #familydollar #unitedstates

Recalls Family Dollar Over-the-Counter Drug & Medical Device products - recalled due to improper storage tem... photo #1
312   Comments Comment

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
312   Comments Comment

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
312   Comments Comment

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
312   Comments Comment

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
312   Comments Comment

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

#amazon #walmart #recall #medicaldevices #unitedstates

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

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
312   Comments Comment

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
312   Comments Comment

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