Class 2 Recall Medical Devices

Medical Device Recalls | FDA

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

The FDA posts 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...

Recalls, Corrections and Removals (Devices) | FDA

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

Recalls Background and Definitions | FDA

https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability …

What Is a Class 2 Medical Device Recall? - Ben Crump

https://bencrump.com/faqs/what-is-a-call-2-medical-device-recall/

Here is a partial list of recent recalls for Class 2 medical devices: Stryker Rejuvenate hip devices Zenith abdominal endovascular graft WallFlex Biliary fully covered stent system …

U.S. FDA classifies recall of Philips' respiratory devices as most ...

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-recall-philips-respiratory-devices-most-serious-2023-02-16/

1 day ago · Follow. Feb 16 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' (PHG.AS) …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

A class I or class II device that is exempt from 510 (k) requirements must still comply with other requirements (known as regulatory controls) unless the device is …

GE HealthCare Recalls Nuclear Medicine Systems for …

https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients

See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; ... Class 1 …

Class 2 Device Recall Altimate Medical

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=197504

Class 2 Device Recall Altimate Medical Class 2 Device Recall Altimate Medical FDA Home Medical Devices Databases 510 (k) DeNovo Registration & Listing …

Class 2 Device Recall Alere - accessdata.fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=194468

Class 2 Device Recall Alere FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | …

Class 2 Device Recall Biograph mCT, Biograph Horizon, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=198099

Class 2 Device Recall Biograph mCT, Biograph Horizon, Biograph Vision FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | …