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 23181–23200 of 38,428 recalls
Recalled Item: A.T.S. 2200TS Tourniquet Systems
The Issue: Updated on-device label and 3 pages of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.T.S. 4000TS Tourniquet Systems
The Issue: Updated on-device label and 3 pages of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empty IntraVia Container with Non-DEHP Fluid Path
The Issue: A leak may allow for microbial contamination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase
The Issue: The VCLAS 3mm, 10mm, and 15mm tip devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iFusion
The Issue: FDA determined that a 510(k) is needed for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iVue with Normative Database
The Issue: FDA determined that a 510(k) is needed for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iVue 500 with iScan
The Issue: FDA determined that a 510(k) is needed for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concorde Lift Torque Limiting Handle. Must be used with supplemental
The Issue: for Intra-operative breakage of driver tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Reaming Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Light Clip for Oracle Retractor
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concorde Lift Driver Shaft AO. Used with supplemental internal spinal
The Issue: for Intra-operative breakage of driver tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Reaming Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Titanium Calibrated Reaming Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0 mm Reaming Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Guide Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 mm Reaming Rod
The Issue: lack of product sterility due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9x15" Medium Utility Positioner with Cover
The Issue: Products may not meet specifications due to possible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7x10" Small Utility Positioner with Cover
The Issue: Products may not meet specifications due to possible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW PICC powered by ARROW VPS Stylet
The Issue: Finished good kits may contain incorrect components. Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter...
The Issue: Finished good kits may contain incorrect components. Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.