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 25181–25200 of 38,428 recalls
Recalled Item: Lap Gallbladder Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lower Extremity Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayview Abdominoplasty Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Recon Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hernia Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stem Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Augmentation Pack
The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascular catheter introduction kit The PICC is indicated for short
The Issue: There have been complaints for peel away sheaths
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: N Latex HCY REAGENT
The Issue: The firm confirmed a reduced once-opened and on-board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS 3 software v. 1.1.4
The Issue: During development of the VIDAS 3 software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Software update for improvements and to resolve several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammomat Inspiration full
The Issue: Software error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite MAC 1
The Issue: The pouch may contain the incorrect Rusch Green
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Systems Calibrator A Kits
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Systems Calibrator A Kits
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Systems Calibrator A Kits
The Issue: Siemens Healthcare Diagnostics has confirmed a negative bias
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The
The Issue: Lima Proximal Bodies were inadvertently re-sterilized. The safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5mm System
The Issue: The identification of the devices was non-conforming with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empowr PS Knee Tibial Insert
The Issue: The Empowr PS Insert was reported as missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System. Used to make treatment plans for patients
The Issue: Incorrect dose after editing beam number an wedge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.