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 5681–5700 of 38,428 recalls
Recalled Item: Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriMed
The Issue: Nail system contains an out of specification driver-socket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Clearview Blower/Mister
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage
The Issue: for unsealed sterile packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Universal Ventilator
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeVentEVO2
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aeris EVO
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo O2
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EV300
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Garbin EVO
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo
The Issue: for sudden loss of ventilation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 28CM STR. BASIC KIT
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 32CM STR. BASIC KIT
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 24CM STR. BASIC KIT
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 28CM STR. BASIC KIT
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.