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 38341–38360 of 38,428 recalls
Recalled Item: Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod
The Issue: Spinal Elements has initiated a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mercury Spinal System DIA 5.5 x 120mm Straight Rod
The Issue: Spinal Elements has initiated a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod
The Issue: Spinal Elements has initiated a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod
The Issue: Spinal Elements has initiated a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod
The Issue: Spinal Elements has initiated a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Encompass The reporting site is using the Encompass software
The Issue: Sunquest is recalling the Sunquest Encompass versions 2.4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long
The Issue: The firm is initiating this recall because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altiva / Exactech Spine
The Issue: Incorrect thread form on the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: lnvatec SpA brand Diver C.E.
The Issue: Devices labeled for an intended use was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IF 8000
The Issue: Zynex notified customers that a malfunction in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Screw Tulip
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.