Who Issues Medical Device Recall Press Releases

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

FDA Provides Update on Recall of Certain Philips …

https://www.fda.gov/news-events/press-announcements/fda-provides-update-recall-certain-philips-respironics-breathing-assistance-machines

November 12, 2021. Español. Today, the U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain …

FDA Orders Philips Respironics to Notify Patients …

https://www.fda.gov/news-events/press-announcements/fda-orders-philips-respironics-notify-patients-regarding-recall-certain-breathing-assistance

The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who …

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

2022 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls

11/01/22. Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu …

Medical Device Model Recall News Release | FDA

https://www.fda.gov/safety/industry-guidance-recalls/medical-device-model-recall-news-release

Model Press Release for recalled medical devices. Product(s) can be identified by provide additional details about how product(s) can be identified.. Company Name voluntarily …

Anatomy of a medical device recall: How defective …

https://www.medtechdive.com/news/medical-device-recall-process-fda-philips-medtronic/608205/

Medical device recalls typically begin with safety or manufacturing issues identified by the device maker, physicians or patients. ... recall notices, press releases …

Statement on agency’s efforts to increase transparency …

https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting

Statement From: In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of …

What is a Medical Device Recall? | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall

A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, an artificial hip) is recalled, it does not always have …

Gaps in Recalls of Home-Use Medical Devices Top …

https://www.prnewswire.com/news-releases/gaps-in-recalls-of-home-use-medical-devices-top-ecris-hazards-list-for-2023-301724735.html

The 10 topics on ECRI's 2023 hazards list are listed below in rank order: Gaps in Recalls for At-Home Medical Devices cause patient confusion and harm. …