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 37821–37840 of 38,428 recalls
Recalled Item: Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
The Issue: It was discovered the CS3000/CS3070 was manufactured using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kimberly Clark Patient Warming System - Model 1000 Control Unit.
The Issue: A defect of the "fuse holder" can lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics Trilogy 100
The Issue: The specified Trilogy units are being recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma
The Issue: failure in the glued seal between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lipofilter 3000
The Issue: Medical device was not manufactured under Good Manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Instructions For Use for the following: Stryker TRIO+ 4.5
The Issue: The front cover of Instructions For Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The brand name of the device is Damon 3MX Bicuspid Bracket
The Issue: The firm initiated the recall as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR
The Issue: When using a Laboratory Information system (LIS) with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUXOR RETRACTOR BASE
The Issue: Stryker received three reports involving blades of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product
The Issue: Sigma is a safety alert for the Master
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Matrix PLF Multiple Sizes Grafton is a human
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Putty Multiple Sizes Grafton is a human bone
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Matrix Strips Multiple Sizes Grafton is a human
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Crunch Multiple Sizes Grafton is a human bone
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optimum Expanse S Multiple sizes Grafton is a human bone
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Flex Multiple Sizes Grafton is a human bone
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grafton DBM Gel Multiple Sizes Grafton is a human bone
The Issue: Multiple lots of GRAFTON ¿ and XPANSE ¿,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.