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 2861–2880 of 38,428 recalls
Recalled Item: Medtronic Pipeline Vantage Embolization Device with Shield Technology
The Issue: Use of embolization device with diameters greater-than-or-equal-to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Pipeline Vantage Embolization Device with Shield Technology
The Issue: Use of embolization device with diameters greater-than-or-equal-to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Connected Blood Glucose Meter
The Issue: Telcare, LLC has received customer complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number:
The Issue: Firm became aware of software issues related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture
The Issue: Increase in complaints concerning "pullwire" breakage that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical Video Processor- Intended to be used with PENTAX
The Issue: During endoscopic procedures using a combination of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization
The Issue: During endoscopic procedures using a combination of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTAX Medical Video Colonoscope- Intended to provide optical visualization of
The Issue: During endoscopic procedures using a combination of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima XR646 HD. X-Ray imaging system.
The Issue: The user can continue to take the next
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Definium 656HD & Discovery XR656HD (GTINs: 00840682138598
The Issue: The user can continue to take the next
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery XR656 HD. X-Ray imaging system.
The Issue: The user can continue to take the next
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery XR656HD. X-Ray imaging system.
The Issue: The user can continue to take the next
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude IDEAL 4 F Hydrophilic Sheath Introducer
The Issue: Hydrophilic Sheath Introducer labeled for 4F dilators may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TISSUE APPROXIMATION SYSTEM (TAS)
The Issue: Tissue approximation straps (zip-ties) have broken before or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH
The Issue: Patient chart stickers provided inside the packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.