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 25441–25460 of 38,428 recalls
Recalled Item: Orthopedic Salvage System (OSS) 9cm prosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10
The Issue: Labeling error: The label indicates the product is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
The Issue: An error can occur causing Delta corrections to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for
The Issue: Customer complaints received for the presence of leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version...
The Issue: A software error caused the window/level to become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IQon Spectral CT with software version 4.7.0 Product Usage: The
The Issue: Multiple issues have caused the device to result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Imager II Angiographic Catheter
The Issue: A field report indicated some units within this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Doripenem DOR32 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Ceftriaxone TXL32 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Vancomycin VA 256 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Ceftazidime TZ256 Foam packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Gentamicin GM256 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ciprofloxacin CI 32 Foam packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Cephalotin CE 256 Foam packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Benzyl Penicillin PG256 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Tobramycin TM256 FOAM packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Fosfomycin FM1024 Blister packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST Imipenem IP32 Foam packaging
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST¿ Ceftriaxone TXL32 SPB
The Issue: Product Stability issues: The current shelf-life claims of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Total Knee
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.