Medical Equipment Recall Failures

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...

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 …

Seven serious medical device failures that have led to urgent …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

If a device is the subject of a recall reportable under 21 CFR Part 806 to address a malfunction, any reportable malfunction of the same nature that involves the same or …

Medical Device Recalls - Food and Drug Administration

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

7 Medical Device Failures Causing …

https://www.mddionline.com/7-medical-device-failures-causing-serious-recalls

Here are seven types of problems we've noticed in recent medical device recalls that FDA has deemed as Class I. 1. Manufacturing Glitches. FDA announced this month that it has given Class I-status …

7 Recent Medical Device Failures …

https://www.mddionline.com/7-recent-medical-device-failures-catching-fdas-eye

Merit Medical Systems has issued a recall over Custom Procedural Trays/Kits containing Hospira-produced 1% lidocaine hydrochloride injection, Hospira itself is recalling one lot of 1% …

5 Staggering Medical Device Recall …

https://www.qualio.com/blog/medical-device-recall-statistics

Let's look at some medical device recall statistics and explore ways in which you can avoid these potentially catastrophic mistakes. 5 Alarming Medical Device Recall Statistics. A medical …

Material failure is root cause of many medical …

https://www.plasticstoday.com/medical/material-failure-root-cause-many-medical-device-recalls

Materials are the major or possible cause of 30 to 40% of FDA recalls for medical devices, according to Jeffrey Ellis, Principal Research Scientist at Battelle (Columbus, OH). The problem begins …

Six of the Worst Medical Device Recalls of 2020

https://www.paulsonandnace.com/six-of-the-worst-medical-device-recalls-of-2020/

Recalled in September after 11 reported injuries and one patient dying, the company instructed medical providers to pull 1,258 of these devices from circulation and return …