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 27341–27360 of 38,428 recalls
Recalled Item: Novation Press-Fit Tapered
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Ceramic AHS Cluster-Hole Shell
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Press-Fit Splined
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Distal Femoral Replacement (patient specific
The Issue: Incorrect component used to manufacture distal femoral replacement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CinchLock SS Knotless Anchor with Inserter
The Issue: Stryker Endoscopy is recalling the CinchLock SS Knotless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CinchLock Flex Knotless Anchor with Inserter
The Issue: Stryker Endoscopy is recalling the CinchLock SS Knotless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquilion Lightning CT System iStation cover
The Issue: Toshiba American Medical Systems, Inc. is recalling the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0
The Issue: Imaging system data may be displayed with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Proton Therapy System - Proteus 235 (brand names: Proteus
The Issue: IBA is conducting a voluntary recall to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus neoBLUE Phototherapy system
The Issue: The firm is adding the warning statement to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVARREST Fibrin Sealant Patch
The Issue: Ethicon is recalling EVARREST Fibrin Sealant Patch because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PerFuse Decompression Instrument PN: 800-0541
The Issue: The Trocar and Plunger Assemblies are missing from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8
The Issue: for software to change the final tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR Systems Unity PACS software
The Issue: Reports were missing demographic header information when they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR Systems Unity PACS software
The Issue: The software is not adding the correct tomo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended
The Issue: The firm became aware of a problem where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray Systems
The Issue: The firm became aware of a problem where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to
The Issue: The firm became aware of a problem where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce
The Issue: The firm became aware of a problem where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMR glenosphere impactor/extractor
The Issue: Complaints of intra-operative breakage of the glenosphere impactors/extractors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.