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 3541–3560 of 38,428 recalls
Recalled Item: Smaxel Fractional CO2 Laser
The Issue: The Smaxel Fractional CO2 Laser does not include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE NEXUS 19/20G CATH CONNECTOR
The Issue: The connectors may not allow catheters to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
The Issue: Deviations in the manufacturing process created a compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat SUV Vacuum Stabilizer System
The Issue: Deviations in the manufacturing process created a compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat-i Positioner. Model Number C-XP-5000Z
The Issue: Deviations in the manufacturing process created a compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter AK 98 Dialysis Machine
The Issue: Baxter is aware of several recalls by other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tandem Intl Bipolar Cocr Shell/UHMWPE Liner
The Issue: The Bipolar assembly contains an oversized Retainer Ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400
The Issue: The Atlan anesthesia workstation either indicated a failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300
The Issue: The Atlan anesthesia workstation either indicated a failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Medline Pacer Implant Pack
The Issue: Some of the suture packages within the convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Medline Open Heart CDS
The Issue: Some of the suture packages within the convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Shoulder Repair Pack-LF
The Issue: Some of the suture packages within the convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV
The Issue: Reported breakage in the tubing Anti-Reflux Valve (ARV)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrganOx metra -Intended as a Normothermic Machine Perfusion system of
The Issue: Battery movement led to damage of one of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.