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 27261–27280 of 38,428 recalls
Recalled Item: GEM(TM)
The Issue: Instructions for use booklet may puncture the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM(TM)
The Issue: Instructions for use booklet may puncture the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acorn 130 Stairlift
The Issue: The design of the seats did not consistently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC
The Issue: Due to some cards in this lot experiencing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX 16-slice SKD whole body computed tomography X-ray system. Imaging
The Issue: The following issues have been found in MX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic
The Issue: The following issues have been found in MX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE
The Issue: An out of tolerance torque tool was used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VITROS¿ Chemistry Products Calibrator Kit 31
The Issue: There is an incorrect value (data/calibration mathematics) on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional
The Issue: The Surgical Table Cushion (HybriGel Pads) could potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radionuclide Radiation Therapy System Product The product is a teletherapy
The Issue: The latches of the frame adapter can be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2 mm Three-fluted drill bit
The Issue: The sterile packaging may be compromised. A protective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product
The Issue: The sterile packaging may be compromised. A protective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge LIS software. The firm name on the label is
The Issue: There are potential issues with results reporting for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.