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 38301–38320 of 38,428 recalls
Recalled Item: MicroCool Breathable Impervious Surgical Gown
The Issue: Complaints were received of gowns pilling or balling,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroCool Breathable Impervious Gown with Secure Fit Surgical
The Issue: Complaints were received of gowns pilling or balling,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety monitor included with System 8000 Base The Sarns" Modular
The Issue: Terumo Cardiovascular Systems (Terumo CVS) received complaints from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter's elastomeric infusion pumps are non-electronic
The Issue: There are reported incidents of leakage on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter's elastomeric infusion pumps are non-electronic
The Issue: There are reported incidents of leakage on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter's elastomeric infusion pumps are non-electronic
The Issue: There are reported incidents of leakage on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Whole Body X--ray Scanner This device is indicated as a
The Issue: 1. It has been found that in raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC IT3000
The Issue: GE Healthcare Surgery had discovered that using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NDI P7 Position Sensor
The Issue: Zimmer CAS voluntarily conducted a retrospective recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular
The Issue: Atlas Spine, Inc. recalled their Apelo Modular Screwdriver,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Loop
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Knife
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrode
The Issue: damage to the sterile packaging (blister tray)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.