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 19441–19460 of 38,428 recalls
Recalled Item: Visions PV .035 Digital IVUS Catheter
The Issue: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve...
The Issue: A percentage of the products shipped in Smartscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve...
The Issue: A percentage of the products shipped in Smartscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve...
The Issue: A percentage of the products shipped in Smartscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve...
The Issue: A percentage of the products shipped in Smartscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve...
The Issue: A percentage of the products shipped in Smartscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-402
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-400
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-RFP-456
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-401
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-RFP-454
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-404
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product...
The Issue: Instructions for Use booklets were not included on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-406
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product...
The Issue: Instructions for Use booklets were not included on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution-RFP-403
The Issue: PureFlow B Solution smaller chamber of the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PLEX Elite 9000
The Issue: Under certain fault conditions, the existing design may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Argon Medical Devices Vascuclamp
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices TRI-JECT
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Argon Medical Devices Double Female LL Adapter
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.