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 29261–29280 of 38,428 recalls
Recalled Item: Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis
The Issue: Complaints that the femoral head could not be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker UniVise Spinous Process Fixation Plate System Inserter
The Issue: The Inserter Inner Shaft would not fit through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120)
The Issue: DePuy Orthopaedics, Inc. is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
The Issue: Software Defects resulting in: (1) sagittal result shortened
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers:
The Issue: Due to a communication error between the software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnVision FLEX/HRP visualization reagent found in the following kits: EnVision
The Issue: There is a defect in one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.0mm Unit Rod 270mm
The Issue: This product was produced using a finishing process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: -Pipeline Embolization Device -Pipeline Flex Embolization Device The...
The Issue: The firm is recalling Pipeline and Pipeline Flex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas b 123 POC system The cobas b 123 POC
The Issue: under specific settings, an issue may occur during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AbsorbENT
The Issue: Summit Medical is recalling Doyle P/F Nasal Pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10)....
The Issue: These Lot numbers are not stable up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A)
The Issue: The firm determined that 25 lots had been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO 400 and AMSCO C Small Steam Sterilizers
The Issue: In AMSCO Small Steam Sterilizers equipped with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare CardioCall ECG Event Recorder
The Issue: When the battery is inserted into the CardioCall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.