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 24061–24080 of 38,428 recalls
Recalled Item: MiniMed 670G Insulin Infusion Pump
The Issue: Medtronic MiniMed is recalling the MiniMed 600 series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 620G Insulin Infusion Pump
The Issue: Medtronic MiniMed is recalling the MiniMed 600 series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 630G Insulin Infusion Pump
The Issue: Medtronic MiniMed is recalling the MiniMed 600 series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 640G Insulin Infusion Pump
The Issue: Medtronic MiniMed is recalling the MiniMed 600 series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. Merge PACS (Picture Archiving Communication System) is
The Issue: When cut lines are shown on an image,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare
The Issue: Merge PACS did not show unviewed images when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable instruments in the Knee
The Issue: Durability characteristics of reusable instruments were not established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Warmer System (IWS)
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arsenal Spinal Fixation System
The Issue: Alphatec Spine is recalling the Arsenal Spinal Fixation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HHV-8 (13810)
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H. pylori (polyclonal} 1.0 mL Catalog number 215A-76
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology -
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herpes Simplex Virus I
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Her2/Neu (EP3)
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adenovirus (20/11 & 2/6)
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD117
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology -
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.