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Safety Reports: Medical Devices

Updated:

Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety, USA

11 months ago •source fda.gov • details

Recall notice

Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture… See more

#recall #medicaldevices #unitedstates

Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety photo #1
312

Busse Hospital Disposals Medical Device Kits and Trays - recalled due to device & drug safety, USA

11 months ago •source fda.gov • details

Recall notice

On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist… See more

#recall #medicaldevices #unitedstates

Busse Hospital Disposals Medical Device Kits and Trays - recalled due to device & drug safety photo #1
312

Covidien and Cardinal Health Urology and OR room specific kits and trays - recalled due to lack of sterility assurance, USA

11 months ago •source fda.gov • details

Recall notice

In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology… See more

#recall #medicaldevices #unitedstates

Covidien and Cardinal Health Urology and OR room specific kits and trays - recalled due to lack of sterility assurance photo #1
312

Baxter Novum IQ syringe infusion pump - recalled due to malfunction, USA

11 months ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and is developing… See more

#recall #medicaldevices #unitedstates

Baxter Novum IQ syringe infusion pump - recalled due to malfunction photo #1
312

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

1 year ago •source fda.gov • details

Recall notice

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

Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP - due to Lack of sterility assurance photo #1
312

Medtronic McGRATH MAC video laryngoscopes - Notification sale of Defective Products illegally by unauthorized third parties, USA

1 year ago •source fda.gov • details

Recall notice

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

Medtronic McGRATH MAC video laryngoscopes - sale of Defective Products photo #1
312

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

1 year ago •source fda.gov • details

Recall notice

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

Family Dollar Over-the-Counter Drug & Medical Device products - recalled due to improper storage temperature photo #1
312

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

1 year ago •source fda.gov • details

Recall notice

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

#medicaldevices #unitedstates

Universal Meditech Inc. Test kits update- recalled due to Product Safety/Defect photo #1
312

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

1 year ago •source fda.gov • details

Recall notice

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

#recall #medicaldevices #unitedstates

Universal Meditech Inc Test kits - recalled due to lacking premarket clearance, risking inaccurate test results photo #1
312

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

#recall #medicaldevices #unitedstates

Dräger Carina Sub-Acute Care Ventilators - recalled due to Product Safety/Potential Foreign Material photo #1
312

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