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 11941–11960 of 38,428 recalls
Recalled Item: BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SmartSite Bag Access Device
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SmartSite 'Y' Extension Set 2 Needle-Free Valves
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SmartSite
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD SmartSite Bag Access Device Needle-Free Valve
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Extension Set SMALLBORE Tubing SmartSite VALVE
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD ADD-ON Burette Set V/NV Needle-Free Valve
The Issue: Needle-free connector valves, either standalone or attached to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steripath Luer Transport Pack
The Issue: Product was shipped with the incorrect Transfer Adapter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phantom Nail System
The Issue: A thin wall condition between the inner cannulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BOND Ready-To-Use Primary Antibody CDX2 (EP25)
The Issue: Product may not perform as specified in IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arjo Disposable Repositioning Sling
The Issue: Sling loop straps on device pose a trip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated...
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems...
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as
The Issue: Pressure relief valve 42 psi installed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.