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Medical Devices

Updated: December 20, 2023 11:01 AM

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

4 months ago •source www.fda.gov

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 #us

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

4 months ago •source www.fda.gov

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 #us

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

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

5 months ago •source www.fda.gov

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 #us

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

5 months ago •source www.fda.gov

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 #us

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

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

6 months ago •source www.fda.gov

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 #us

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

6 months ago •source www.fda.gov

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

#recall #medicaldevices #drugs #familydollar #us

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

7 months ago •source www.fda.gov

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 #us

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

8 months ago •source www.fda.gov

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 #us

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

9 months ago •source www.fda.gov

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 #us

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

9 months ago •source www.fda.gov

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 #us

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Medical Devices

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

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

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

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

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

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

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

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