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 23661–23680 of 38,428 recalls
Recalled Item: PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal
The Issue: Devices are not consistent with Quality System Requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ(R) Oncology Information System
The Issue: Retention of Outdated Information in an Order Set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Unit Abutment Angled
The Issue: Abutments are unable to accept the final abutment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellicuff Standalone (PN 951001) Used to continuously measure and...
The Issue: Issue related to the performance of the motor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
The Issue: The firm has identified that a fitting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary
The Issue: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets
The Issue: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning
The Issue: Incorrect PEC values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855
The Issue: Software- scheduled A-QC analysis could initiate prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nussloch GmbH ASP6025 Tissue Processor
The Issue: Incorrect labeling for specified voltage for the Alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant
The Issue: An 8mm diameter bone tap was laser marked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 300 Intra-Aortic Balloon Pump
The Issue: The device failed to pump due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 100i Intra-Aortic Balloon Pump
The Issue: The device failed to pump due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 100 Intra-Aortic Balloon Pump
The Issue: The device failed to pump due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.