Recalls

Reason for Device Correction The MiniMed 508 insulin pump and the MiniMed Paradigm series insulin pumps are designed to communicate using a wireless radio frequency (RF) with other devices such as blood glucose meters, glucose sensor transmitters, and CareLink USB devices. Security researchers identified potential cybersecurity vulnerabilities related to these…

About the Recall: DeVilbiss Healthcare is voluntarily implementing this correction to replace the instruction manual with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. DeVilbiss Healthcare decided to initiate this correction after reviewing the current standard and identifying the clarifications needed. Risk to…

About the Recall: Philips Respironics has issued an urgent product notice regarding the Philips Respironics SimplyGo portable oxygen concentrator that could affect the performance of the equipment. Philips identified a potential failure of SimplyGo Oxygen Concentrators built between July 27, 2021- January 18, 2022, if the concentrator is used on…

About the Recall: Insulet Corporation has issued an urgent medical device correction regarding the Omnipod® 5 Automated Insulin Delivery System. Insulet Corporation has received 24 reports from Omnipod 5 users where the Omnipod 5 Controller charging port (USB-C port) and charging cable (USB cable) are melting, deforming, or discoloring due…

About the Recall: Convatec has issued an Urgent Product Recall regarding one lot of their Aquacel Foam Ag Adhesive Dressings. This reason for the recall is due to the identification of visual contamination in the form of brown spots present on several dressings. If you have any questions about the…

About the Recall: Cardinal Health has initiated a voluntary recall on specific lots of Dover™ Closed Urethral Tray with Vinyl Catheter and Dover™ Closed Urethral Tray with Hydrogel Coated Red Rubber Latex Catheter. The potential is for an occlusion (blockage) of the bubble inlet port of the urinary drainage bag…

About the Recall: The U.S. Consumer Product Safety Commission (CPSC) and NOVA Ortho-Med Inc. have issued a voluntary recall of two models of the company’s bed rails. The reason for the recall is due to a safety issue when the bed rails are attached to an adult’s bed. Users can…

About the Recall: Lyons Magnus (“Lyons”) has initiated a voluntary recall regarding specific lots of their Abbott Nutrition products distributed by McKesson Medical-Surgical (MMS). Lyons is conducting this voluntary recall due to the potential for microbial contamination including the organism Cronobacter sakazakii and Clostridium botulinum. Cronobacter sakazakii can cause severe…

About the Recall: Löwenstein Medical Technology has initiated a voluntary field safety notice in connection with a potential hazard due to the influence on the ventilation function of the LUISA (LM150TD) ventilator. The potential is for a malfunction of the inspiratory trigger of the LUISA ventilators with firmware version 1.5.0030…

About the Recall Cardinal Health is initiating an Urgent Medical Device Field Correction to advise of the potential for air appearing in the enteral feed pumping set tubing during set up. The potential is for air entry into the feeding set tubing that could result in the following health consequences:…