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 22381–22400 of 38,428 recalls
Recalled Item: ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring
The Issue: Due to a software error, it was observed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triage Drugs of Abuse Plus TCA 25 Test Kit
The Issue: The recalled lots have demonstrated unexpected false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy Programmer
The Issue: Certain Model 3000 programming events can result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline
The Issue: A programing error in some Model FD100 HomeSafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps
The Issue: Certain Medfusion Syringe Pump Models, Series 3100, 3500,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps
The Issue: Certain Medfusion Syringe Pump Models, Series 3100, 3500,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps
The Issue: Certain Medfusion Syringe Pump Models, Series 3100, 3500,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Piranha Screw 4.0 x 12mm
The Issue: incorrect marking and color identification of Piranha
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CritiCore Automated Urine Output and Temperature Monitor
The Issue: Issues identified with the monitor including urine output
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100
The Issue: iQ200 Series Urine Microscopy Analyzer may intermittently fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with
The Issue: Using different fluid formulations of NxStage PureFlow B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
The Issue: Internal program testing shows that product may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.