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 3621–3640 of 38,428 recalls
Recalled Item: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imed Products Imed EVA BAG
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed)
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed)
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imed Products Imed EVA BAG
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports
The Issue: A limited number of IV bags have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONOCRYL" (poliglecaprone 25) Suture MONOCRYL" Sutures are indicated
The Issue: Due a component mix-up in manufacturing, the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Approach Hydro ST Micro Wire Guide
The Issue: Affected device lots have labels that state the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Approach CTO Micro Wire Guide
The Issue: Affected device lots have labels that state the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
The Issue: The user of the assay may either face
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive
The Issue: for in-line nebulizer configuration in certain locations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EV300. Model Numbers: DS2200X11B
The Issue: for in-line nebulizer configuration in certain locations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive
The Issue: for in-line nebulizer configuration in certain locations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive
The Issue: for in-line nebulizer configuration in certain locations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive
The Issue: for in-line nebulizer configuration in certain locations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Zenition 50
The Issue: for the Mains Control Unit board fuse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.