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Recalls

Recalls

Device Correction – SoClean

About the Recall: SoClean has received approximately 7,417 complaints resulting from improper set-up, unauthorized device modifications, and use by individuals for whom the device is not recommended as indicated in the user manual. Common complaints include the customer not being able to set up or turn to the device, mildew…
Chris Camera
January 24, 2024
Recalls

Recall – Breas Medical, INC 

About the Recall: This recall was issued duet to a field safety notice from Intersurgical Ltd., the manufacturer of the NIV Angled Mouthpiece with Notch 22F/15F, indicating some lots were produced with unintended open slits on the side of the mouthpiece body.  This allows some of the respiratory gas to…
Chris Camera
January 24, 2024
Recalls

Recall – UnoMedical – Tandem infusion Sets

About the Recall: Unomedical, manufacturer of Tandem infusion sets, has informed us of a voluntary recall involving VariSo infusion sets. As a valued distribu on partner of Tandem Diabetes Care, we ask that you promptly act as outlined below. Description of problem: Unomedical a/s has found that in rare cases…
Chris Camera
January 24, 2024
Recalls

Recall – Medline-Various Tracheostomy Care and Cleaning Trays

About the Recall: This notice has been issued due to the tracheostomy brush (a component of the Tracheostomy Care and Cleaning Kits) having a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Manufacturer Notice/Web Site: https://recalls.medline.com/ Actions to be taken by customer/Patient:…
Chris Camera
January 24, 2024
Recalls

Medical Device Correction – Philips

About the Recall: Clear overview of recall and products affected Voluntarily “Urgent Medical Device Correction” for the M5071A Adult and M5072A Infant/Child Pads Cartridge for use with HS1/Onsite/Home AEDs. Specific products(s) numbers/models that are affected: M5071A Adult and M5072A Infant/Child Pads Cartridge for use with HS1/Onsite/Home AEDs. Manufacturer Notice/Web Site:…
Chris Camera
December 12, 2023
Recalls

Recall – Sentec

About the Recall: The Membrane Changers (REF: MC, MC-R and MC-I) are used to change the membranes on your V-Sign™ 2 or OxiVenT™ sensors. This is part of routine maintenance as outlined in the Instruction Manuals (HB-005771-r, HB-011077-_, HB-005147-m, HB-006417-d). What is the defect? During the manufacturing process there were…
Chris Camera
December 12, 2023
Recalls

Device Correction: GE HealthCare – McKesson

About the Recall: Company has notified McKesson Medical-Surgical Inc. (MMS) of an Urgent Drug/Product/Medical Device Information/Safety Notification regarding one/specific lot(s) of their Product Name. This notification has been issued because/due to reason for the notification here. Affected product first shipped June 29, 2013. Specific products(s) numbers/models that are affected: Manufacturer…
Chris Camera
November 29, 2023
Recalls

Recall: Smith Medical – McKesson

About the Recall: Smiths Medical has notified McKesson Medical-Surgical Inc. (MMS) of an Urgent Medical Device Correction regarding specific lots of their CADD™ Infusion System Infusion Sets for use with CADD pumps. This is an update to the notice from 09 December 2022. Smiths Medical has identified additional lots of…
Chris Camera
November 29, 2023
Recalls

Recall: Ascensia Diabetes Care (ADC)

About the Recall: Ascensia Diabetes Care (ADC) has notified McKesson Medical-Surgical Inc. (MMS) of an Urgent Medical Device Recall regarding one lot of their CONTOUR® NEXT Gen Blood Glucose Meters. This notice has been issued because ADC has determined through customer complaints (22 complaints till 15-Jun-2023) that 579 meters distributed…
Chris Camera
November 29, 2023