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 8381–8400 of 38,428 recalls
Recalled Item: Magic3 Go Intermittent Urinary Catheters
The Issue: Some catheters had a manufacturing defect where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Information Center iX
The Issue: During extended operation of the MX40 with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Single Use Distal Cover Model Number MAJ-2315 used with
The Issue: The Single Use Distal Cover MAJ-2315 may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Pack
The Issue: Incorrect expiration date on product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile custom surgical procedure packs (1) 89-10529.04
The Issue: The custom procedure packs contain light handle covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile custom surgical procedure packs: (1) 89-10507.02
The Issue: The custom procedure packs contain light handle covers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative
The Issue: for both unexpected positive and negative HbA1c
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (P)180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Set2Go Ventilation 12 (A)
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Seattle PAP Plus
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Anesthesia WT (P)180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Set Coax 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist catheter is an intravascular micro axial
The Issue: The Impella 5.5 pump experienced a heightened complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Watertrap (N) 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Watertrap (P) 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Anesthesia (N) 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventstar Coax
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Basic (P) 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (P)250
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Coax 3
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.