The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind. This action is a correction, not a product removal. Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. […]
Recalls
Insulet has a Class I recall for the Omnipod 5 Android App
The FDA labeled a recall of the Insulet Omnipod 5 App for Android smartphones as Class I, the most serious kind. Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. […]
FDA says not to use certain hip implants from Synovo
The FDA today issued recommendations for providers considering using the Total Hip System and its implants made by Synovo. Its recommendations also apply to patients who received certain implants used in the system after 2019. Three components — the femoral resurfacing cup, acetabular fixation cup and acetabular bearing — have been significantly modified from the […]
Report: Concerning chemicals found in replacement Philips CPAPs
Replacement machines issued by Philips amid its respiratory device recall may have more issues, according to ProPublica and the Pittsburgh Post-Gazette. Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at […]
Philips recalls MRI system due to risk of exploding
The FDA says a recall of Philips Panorama 1.0T HFO magnetic resonance imaging (MRI) systems is Class I, the most serious kind. Philips recalled the MRI system due to a risk of explosion during a quench procedure. The excessive pressure buildup of helium gas could cause this. To date, Philips has received reports of one […]
ResMed warns on updates to masks with magnets
ResMed announced today that it’s conducting a voluntary global field action to update guides for all masks with magnets. San Diego-based ResMed informed users of potential magnetic interference when magnets go near certain implants and medical devices in the body. The company doesn’t require a return of a mask with magnets unless the patient is […]
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
Olympus bronchoscopes in Class I recall could lead to burns, fire
The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind. Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death. This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and […]
Medtronic has a Class I recall for its surgical navigation software
The FDA deemed the recall of Medtronic StealthStation S8 software Class I, the most serious kind. This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall […]
U.S. senators call for review of FDA following Philips recall fallout
Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Respironics recall. Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled […]
BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes
The FDA determined that another recall of BD Alaris infusion pumps is Class I, the most serious kind. In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices. BD’s […]