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 34621–34640 of 38,428 recalls
Recalled Item: CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser
The Issue: for patient to be marked incorrectly. Customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension
The Issue: When utilizing the Routine Inventory screen to enter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus "
The Issue: As the result of a recent internal review
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product
The Issue: Mindray has identified an issue with V Series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENESIS(R) II
The Issue: Swapped product. Non-porous tibial base size 5 L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm
The Issue: A small number of units in lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENESIS(R) II
The Issue: Swapped product. Non-porous tibial base size 5 L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products COCM Reagent
The Issue: Inaccurate quality control results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is
The Issue: Individual pieces of a batch of Biomet's Endobon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invivo Corporation Expression IP5 Information Portal Product Usage: The...
The Issue: Invivo Corporation located at 12151 Research Parkway, Orlando,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERITITE Containers: STERITITE Container Kit
The Issue: Advanced Sterilization Products (ASP) is recalling the SteriTite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Analyte Urine DAU Control (5 m L Norbuprenorphine
The Issue: Product catalog # A68825 Norbuprenorphine 13 ng/mL Level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes...
The Issue: A potential exists for non conforming Synthes Titanium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual
The Issue: Complaints were received for intraoperative reamer head breakages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for...
The Issue: Manufactured with an incorrect factory set unit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for...
The Issue: Manufactured with an incorrect factory set unit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is
The Issue: Beckman Coulter is initiating a recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EkoSonic Endovascular System employs high frequency (2-2.5 MHz)
The Issue: The EkoSonic Control Unit is recalled because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: It was discovered that the silicone potting failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.