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 13661–13680 of 38,428 recalls
Recalled Item: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in
The Issue: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APEX Compounding System Control Panel Module
The Issue: There is the potential for the compounding system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version
The Issue: There is a potential software error during programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: There is a potential software error during programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version
The Issue: There is a potential software error during programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APEX Compounding System Control Panel Module
The Issue: There is the potential for the compounding system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version
The Issue: There is a potential software error during programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Laboratory Automation System
The Issue: A software anomaly may cause an aliquoted sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Automation Solutions
The Issue: A software anomaly may cause an aliquoted sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinal Rod Cutter
The Issue: Device has the potential for fracture during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haag Streit Surgical Floor stands FS 2-11 (. 615H511)
The Issue: Software error -Software REF 615 588 versions 2.0
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLS Set Advanced Model Name: BEQ-HLS 5050 USA
The Issue: The HLS Set Advanced (disposable for Cardiohelp) is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLS Set Advanced
The Issue: The HLS Set Advanced (disposable for Cardiohelp) is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Pump Implant Kits
The Issue: Pumps manufactured with impellers from a subset of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medisafe Distal Duck Kit and Duck Bag
The Issue: STERIS has identified that certain lots of diluted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The cobas z 480 analyzer including dedicated software for IVD
The Issue: Dirty Lens May Cause Invalid or False Positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emission Computed Tomography System Image Process System - Product Usage:
The Issue: A software defect that has the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CM 50-001-01 Injectate Kit
The Issue: The expiration date on labeling is incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.