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 13301–13320 of 38,428 recalls
Recalled Item: Lab Coats SMS 2X-Large Blue
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Kendall Blue XXL
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Kendall Blue L
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHILIPS BATTERY
The Issue: Due to unqualified "design verification" batteries being shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusion Pump
The Issue: Battery performance issues related to prolonged storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9180 Electrolyte Analyzer - Product Usage: intended to be used
The Issue: May display Calcium results on the screen with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for
The Issue: The lidstock / information card on the kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-H900 Humidifier
The Issue: When starting a humidifier, intended for respiratory gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade Abrazo aPTT Test Card - Product Usage: are to
The Issue: Intermittent potential for shorter than expected clot times
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nucleic acid-based in vitro diagnostic devices for the detection of
The Issue: Users cannot complete testing due to a sign-error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX 25G 2.5MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KD-611L ELECTROSURGICAL KNIFE
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-202 GUIDE SHEATH KIT 2.0MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEEDLEMASTER 3MMx 23G LOWER
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SD-230U-20 ELECTROSURGICAL SNARE
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PR-V614M 2-LUMEN CANNULA
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B7-2LA BALLOON CATHETER 13MM DIA 3.2
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM
The Issue: Inspection confirmed a small percentage of sterile packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.