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 21741–21760 of 38,428 recalls
Recalled Item: IMRIS ORT300 Removable Operating Room Table
The Issue: The rotational locking mechanisms on the ORT 200/300
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINI INFANT < 3KG
The Issue: Wire sets of certain devices were assembled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12F Tesio CATHETER SET (CUFF 32CM FROM TIP)
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12F Tesio CATHETER SET (CUFF 22CM FROM TIP)
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REPAIR KIT
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATHETER REPAIR KIT
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWO PART ADAPTER
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATHETER REPAIR KIT
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REPAIR KIT
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12F MODIFIED Tesio CATHETER SET
The Issue: There is the potential for connection failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas b 221 AutoQC Module Complete
The Issue: The software responsible for starting scheduled AutoQC measurements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and
The Issue: The software responsible for starting scheduled AutoQC measurements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas b 221<6>Roche OMNI S6 system
The Issue: The software responsible for starting scheduled AutoQC measurements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas b 221<4>Roche OMNI S4 system
The Issue: The software responsible for starting scheduled AutoQC measurements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: True 3D Viewer
The Issue: With certain software versions, import of enhanced ultrasound
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOSTAT II IgM Rheumatoid Factor
The Issue: Reports of higher than anticipated positivity rate for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph Horizon
The Issue: Possibility that the Biograph Horizon systems performing CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: clariti 1 day (-1.25) 90 pack
The Issue: The secondary packaging is labeled with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.