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 721–740 of 38,428 recalls
Recalled Item: Olympus OER-Pro
The Issue: Inform existing affected device customers about pertinent Warnings/Cautions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX550. Product Number: 866066.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX750. Product Number: 866471.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus OER-Mini
The Issue: Inform existing affected device customers about pertinent Warnings/Cautions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX450. Product Number: 866062.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MP70. Product Number: M8007A.
The Issue: issue where the IntelliVue monitors did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NICO BrainPath
The Issue: Tape used to secure components within packaging contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP
The Issue: Tape used to secure components within packaging contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber
The Issue: Tape used to secure components within packaging contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
The Issue: Invitro diagnostic test kits with specimens that have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
The Issue: Invitro diagnostic test kits with specimens that have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Ligating Device Product Name: Olympus HX-400U-30
The Issue: that the ligation loop was unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX)
The Issue: The Aliquoter Module (mALX) may generate secondary sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX)
The Issue: The Aliquoter Module (mALX) may generate secondary sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea
The Issue: Due to complaints, orthopedic rotation tool handle may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea
The Issue: Due to complaints, orthopedic rotation tool handle may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1ml of DTT in liquid phase
The Issue: Treatment reagent functionality in respiratory specimens liquification cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1ml of DTT in liquid phase
The Issue: Treatment reagent functionality in respiratory specimens fluidification cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IV Administration Set utilized in gravity IV administration sets and
The Issue: for backflow of medication from secondary (piggyback)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IV Administration Set utilized in gravity IV administration sets and
The Issue: for backflow of medication from secondary (piggyback)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.