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 14721–14740 of 38,428 recalls
Recalled Item: Alaris PCA Module Model 8120 - Product Usage: is intended
The Issue: LED display, which provides infusion or patient monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pleur-Evac Adult-Ped Wet
The Issue: for sterile packaging to be compromised¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8015
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
The Issue: If one or more screws or washers are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module Model 8100
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module Model 8100
The Issue: Broken elements on pump module platen such as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris EtCO2 Module Model 8300
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Auto ID Module Model 8600
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris SpO2 Module Model 8210 and Model 8220
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DCA Vantage Handheld Barcode Scanner - Zebra Model - Model
The Issue: If DCA Vantage Analyzer is configured to run
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8000
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PCA Module Model 8120
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
The Issue: If one or more screws or washers are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Syringe Module Model 8110
The Issue: Cleaning agents may damage Inter-Unit Interface (IUI) Connectors,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pleur-Evac Adult-Ped Wet
The Issue: for sterile packaging to be compromised¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Progressa Bed
The Issue: Affected beds may have screws installed that do
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearPro Trach T-Piece Closed Suction Catheter
The Issue: There are reports of the suction catheter coming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centrella Smart+ Bed
The Issue: Affected beds may have screws installed that do
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearPro T-Piece Closed Suction Catheter
The Issue: There are reports of the suction catheter coming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX800 patient monitor
The Issue: Some Intellivue MX700/MX800 Patient Monitors were delivered with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.