Medical Devices Recalls

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.

2021 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls

Dec 16, 2021

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 Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

2023 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls

2022 Medical Device Recalls. Device Name. Date. Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing …

GE HealthCare Recalls Nuclear Medicine 600/800 …

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; Date …

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/

2 days ago · The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' respiratory machines as most serious, …

Recalls, Corrections and Removals (Devices) | FDA

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

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a …

Medical Device Recall Information - Philips …

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued …

Class 2 Device Recall Biograph mCT, Biograph Horizon, …

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

The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more …