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 5781–5800 of 38,428 recalls
Recalled Item: Ingenia 1.5T
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYROSCAN T10-NT
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 3.0T Quasar Dual
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Master/Nova
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology
The Issue: Product incorrectly labelled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses
The Issue: System error messages may delay the ability to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Identity Imprint PS Tibial Tray Size 4: Lot 540287
The Issue: Size 5 Tibial Tray from Lot 508287 was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who
The Issue: Black particulate matter from the carbon filter component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who
The Issue: Black particulate matter from the carbon filter component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ureteral dilator
The Issue: A possible sterility issue (e.g. a breach in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HDS Traction Boot II
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Galaxy System (specifically GAL-019
The Issue: Due to a misaligned calibration of the wired
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Route 92 Medical
The Issue: Their is the potential for distal tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Route 92 Medical
The Issue: Their is the potential for distal tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Route 92 Medical
The Issue: Their is the potential for distal tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Route 92 Medical Full Length 070 Access System
The Issue: Their is the potential for distal tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Route 92 Medical 070 Reperfusion System
The Issue: Their is the potential for distal tip separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.