Tag: Recall
Dexcom issues correction for G6 software
January 5, 2026HME News Staff
WASHINGTON – Dexcom has issued a correction for Dexcom G6 and G6 Pro Software due to an identified bug that can cause the app to terminate unexpectedly, according to the U.S. Food and Drug Administration (FDA). As a result of the bug, the user may not receive estimated glucose values, alarms or alerts. If a user is unaware that the app has terminated, there is potential for missed detection of a high blood sugar (hyperglycemic) or...
Max Mobility/Permobil expands recall of SpeedControl Dial for SmartDrive MX2+
September 10, 2025HME News Staff
LEBANON, Tenn. – Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This expanded recall now includes all SpeedControl Dials manufactured and distributed between April 25, 2022, and July 8, 2025.
Background and prior recalls
The original Class I recall (Z-1116-2025, Z-1117-2025, RES #96086) was initiated on Dec. 20, 2024, targeting SpeedControl...
DermaRite Industries issues voluntary nationwide recall of several product lines
August 13, 2025HME News Staff
NORTH BERGEN, N.J. – DermaRite Industries is voluntarily recalling individual lots of products due to microbial contamination identified as Burkholderia cepecia, which can result in serious and life-threatening infections. To date, DermaRite has not received any reports of adverse events related to this recall. Affected products are:
DermaKleen, an OTC antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
DermaSarra,...
Philips navigates tough comp in second quarter, forecasts pick up in second half
July 30, 2025Liz Beaulieu, Editor
AMSTERDAM – Philips has seen “a bit slower pickup” for Sleep & Respiratory Care so far this year, but it expects momentum to grow in the third and fourth quarters, says CEO Roy Jakobs.
S&RC, part of the Connected Care business, saw a strong pickup last year, but that created tough comps for the first and second quarters this year, Jacobs noted during a call to discuss recent financial results.
“We have strong momentum in masks, where the new launches are...
Dexcom recalls certain receivers due to speaker malfunction
July 22, 2025HME News Staff
SAN DIEGO – Dexcom is recalling certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because of a problem with the speaker that may cause it to fail to make an alert sound when blood sugar is dangerously low or high.
The use of affected products may cause serious adverse health consequences, including seizures, vomiting, loss of consciousness and death, according to the U.S. Food and Drug Administration.
There have been at least 56 reported injuries. There have...
Drive DeVilbiss initiates recall on car adapter
July 21, 2025HME News Staff
WASHINGTON – Drive DeVilbiss Healthcare is recalling the iGo2 DV6X-619 DC car adapter, a non-critical accessory to the iGo2 Portable Oxygen Concentrator (POC), due to complaints of the DC power cord being hot to the touch and/or melting while being used, according to the U.S. Food and Drug Administration. The iGo2 POC is a DC-powered, variable motor/compressor speed oxygen concentrator that can be operated from an AC, DC or battery power source. Use of the affected product may cause serious...
Urgent recall issued for TrueAire-5 oxygen concentrator
February 6, 2025HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has issued an urgent recall for the JMCC5A Ni/TruAire-5 Oxygen Concentrator due to the device spontaneously catching fire. The FDA says all units from a specified serial number range must be immediately discontinued from use and removed from service and promptly returned to Compass Health Brands. The affected devices are Model O2C5L with serial number range JA2311000001-JA2312000740. On Nov. 26, 2024, Jiangsu Jumao X-Care Medical Equipment...
Philips updates vent instructions
November 25, 2024HME News Staff
WASHINGTON – Philips has updated its instructions for using Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin EVO and LifeVent EVO2 due to risk of inaccurate flow measurements caused by certain in-line nebulizer placements, according to the U.S. Food and Drug Administration. The company says to be aware that this issue may affect any device that has ever been used with in-line nebulizer treatments. The updated instructions include making sure all alarms are set appropriately and keeping...
Abbott recalls certain sensors
September 9, 2024HME News Staff
ABBOTT PARK, Ill. - Abbott has issued a recall for certain FreeStyle Libre 3 sensors due to a risk for inaccurate high glucose readings. On July 24, the company sent all affected customers an urgent medical device recall recommending they, among other things, immediately discontinue use and dispose of any affected sensors, and request a replacement for any affected seniors. Abbott initiated the recall after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose...
Tandem offers update on recall
August 21, 2024HME News Staff
SAN DIEGO – Tandem Diabetes Care on Aug. 9 emailed notices to customers impacted by a recall of its Apple OS t:connect mobile app. The recall, issued in March, relates to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery, causing the insulin pump to shut down sooner than expected. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Tandem strongly...