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 14741–14760 of 38,428 recalls
Recalled Item: IntelliVue MX700 patient monitor
The Issue: Some Intellivue MX700/MX800 Patient Monitors were delivered with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERI-LOC TARGETER 4.5MM DISTAL FEMUR
The Issue: The 4.5MM PeriLoc Targeter right hand part was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PVA
The Issue: While operating the machine in "Run" mode an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip
The Issue: The tungsten carbide plate, which is intended to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon EUS Access System Preloaded Access 135degree Needle sterile
The Issue: This voluntary recall is being conducted following three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage:
The Issue: Randox have confirmed imprecision of quality control and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon EUS Access System Preloaded Access 90degree Needle sterile
The Issue: This voluntary recall is being conducted following three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump Model 4000
The Issue: Inaccurate delivery can occur following an interrupted Bolus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage:
The Issue: Randox have confirmed imprecision of quality control and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A
The Issue: Randox have confirmed imprecision of quality control and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump Model 3500
The Issue: Inaccurate delivery can occur following an interrupted Bolus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InnoWave Sonic Irrigator
The Issue: A recent FDA inspection at the firm identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue G7m Anesthesia Gas Module
The Issue: The device may experience an interruption of gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepIT Q2A Kit
The Issue: Reagents were shipped to customers after the Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX ULTRA Suture
The Issue: A packaging error resulted in a XL drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew T-F1X0 RCG Drill Pac
The Issue: The T-Fix sterile package contains only one sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Low Profile Screw
The Issue: Screws provided in packaging are 5mm shorter than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN
The Issue: A manufacturing error which resulted in the re-sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
The Issue: If the user modifies for any reason (e.g
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurosign V4 Intraoperative Nerve monitor family of devices.
The Issue: Reports that manipulation of the cable which connects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.