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 8901–8920 of 38,428 recalls
Recalled Item: HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T-
The Issue: Anti-HBe2 (aHBe2) interference with the Hepatitis B e
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term
The Issue: Label with the incorrect component listed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Covera Vascular Covered Stent is a flexible
The Issue: An increase in the reported complaint rate for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RipCord Syndesmosis Button
The Issue: Overly aggressive tension on the pull suture, while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE UNITE FOOT & ANKLE DRILL BIT
The Issue: The recall is due to observed intra-operative screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE UNITE FOOT & ANKLE Screw
The Issue: The recall is due to observed intra-operative screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE UNITE FOOT & ANKLE Screw
The Issue: The recall is due to observed intra-operative screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA
The Issue: There is an orogastric (OG) tube size discrepancy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge Flow-e Anesthesia System
The Issue: Due to a software bug, under certain conditions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge Flow-c Anesthesia System
The Issue: Due to a software bug, under certain conditions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge Flow-i Anesthesia Systems Flow-i C20
The Issue: Due to a software bug, under certain conditions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software : myNeedle Guide 2D license
The Issue: In the syngo.CT VA40 and syngo.CT VA50 myNeedle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA
The Issue: There is an orogastric (OG) tube size discrepancy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vasoshield Syringe Packs
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemopro 2 with Vasoshield
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the
The Issue: A single CF-Q180AL colonovideoscope was utilized in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos dRF Max with software VE10
The Issue: risk of collision with the ceiling, wall,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminos Agile Max with software VE10 & VF11- A diagnostic
The Issue: risk of collision with the ceiling, wall,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uroskop Omnia Max with software VE10 & VF11- A diagnostic
The Issue: risk of collision with the ceiling, wall,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.