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 33881–33900 of 38,428 recalls
Recalled Item: 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage:
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex)
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint APEX Helix
The Issue: safety issue related to unintended radial detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The
The Issue: safety issue related to unintended radial detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR
The Issue: In an abundance of caution, Aperio (now known
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For
The Issue: safety issue related to unintended radial detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMP X-alt Acetabular Liner This acetabular liner is intended for
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MORPH ACCESSPRO Steerable Introducer
The Issue: Tyvek packaging may be worn, causing loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RaySearch Ray Station
The Issue: RaySearch Laboratories has recalled RaySearch Ray Station 4.0
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Radiation Therapy Treatment Planning System
The Issue: for dose errors due to software program
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart FR3 Automated External Defibrillator (AED)
The Issue: Philip's is recalling HeartStart FR3 Automated External Defibrillator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart Home and OnSite (HS1) automated external defibrillators...
The Issue: Philips is recalling HeartStart Home and OnSite (HS1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution
The Issue: Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution
The Issue: Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Everest 20cc Inflation Device
The Issue: Incorrect master label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisherbrand Sterile Swabs
The Issue: A customer reported the presence of an organism
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen
The Issue: Alere San Diego, Inc. is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 5.0mm Variable Locking Screw This device is part of
The Issue: Labeling correction: The package insert in one 5.0mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.