Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 15641–15660 of 38,428 recalls
Recalled Item: Avalon Elite Vascular Access Kit
The Issue: A lot of Avalon Elite Vascular Access Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software
The Issue: Menu selections for users to access the oxygen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 8B Service Pack 2
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 8A Service Pack 1
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 8B Service Pack 1
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 9B
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 8B
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 8A
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan 9A
The Issue: There is a potential for erroneous propagation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0
The Issue: Software defect in TEG Manager impacts the displayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels
The Issue: Tests returning incorrect susceptible results. High Level Gentamicin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels
The Issue: Tests returning incorrect susceptible results. High Level Gentamicin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic
The Issue: Tests returning incorrect susceptible results. High Level Gentamicin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels
The Issue: Tests returning incorrect susceptible results. High Level Gentamicin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK
The Issue: Tests returning incorrect susceptible results. High Level Gentamicin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON M2/Primus Mid-Energy Model #01940035
The Issue: safety issue with the dose monitoring system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Avante Garde #5863472
The Issue: safety issue with the dose monitoring system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE MV System Model #8139789 with Digital LINAC Systems Control
The Issue: safety issue with the dose monitoring system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Firefly Floorsitter
The Issue: The firm received reports of a number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software
The Issue: safety issue with the dose monitoring system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.