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 12321–12340 of 38,428 recalls
Recalled Item: Edwards VAMP Jr. 6 in (15 cm)
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave (3 cc)/VAMP Jr
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave (30 cc)/VAMP Jr Kit
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit
The Issue: There is a potential that the pressure tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Physician Order Form (PL-15400-00
The Issue: Physician Order Form (PL-15400-00 Nov 2018) distributed is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OxyMask O2 Adult
The Issue: for oxygen tubing to disconnect from mask
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360
The Issue: for mold contamination (Aspergillus vadensis)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempus Pro - Patient physiological monitor
The Issue: The Tempus Pro (Trizeps 7 only) when used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
The Issue: Masimo SpO2 Saturation Values can become frozen after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Vantage Titan 3T
The Issue: The MRI system contains a component that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba Vantage Tiitan 1.5T with Standard gradient
The Issue: The MRI system contains a component that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Vantage Tiitan 1.5T
The Issue: The MRI system contains a component that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Vantage Galan 3T
The Issue: The MRI system contains a component that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Femoral Angiography Drape with Single Pouch
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile Femoral Angiography Drape
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile Femoral Angiography Drape with Single Pouch
The Issue: The plastic film used to manufacture these Angiography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.