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 35821–35840 of 38,428 recalls
Recalled Item: Brainlab Cranial Navigation System: An Image Guided Surgery System /
The Issue: Software Error: The effect of setup on overall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HbA1c Flex(R) reagent cartridge (K3105A
The Issue: Positive bias on the lots listed compared to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HB1C Flex(R) Reagent Cartridge (DF105A
The Issue: Positive bias on the lots listed compared to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Adult Manual Resuscitator
The Issue: CareFusion has received four (4) customer reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Case Lid and Base (Inspan
The Issue: Non-toxic inks, used on the silk screen graphics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure).
The Issue: Fisher and Paykel Healthcare is recalling the ICON
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24
The Issue: Advanced Sterilization Products is recalling certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Enterprise Archive is a software product for receiving
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x
The Issue: Post Market Surveillance of the 90 degree Cannulated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x
The Issue: Post Market Surveillance of the 90 degree Cannulated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x
The Issue: Post Market Surveillance of the 90 degree Cannulated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Cannulated Distal Femoral Nail (Trauma Nail)
The Issue: Firm discovered that a nail that was within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zeiss brand OPMI Pentero C
The Issue: Carl Zeiss Meditec is conducting a field corrective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm
The Issue: Cook Medical has received a small number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zilver PTX Drug-Eluting Peripheral Stent
The Issue: Cook Medical has received a small number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS D-Dimer Exclusion II
The Issue: Customer complaints about not repeatable results below the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xlumena brand NAVIX Access Device
The Issue: A complaint investigation has found that product fractures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFIDENCE SPINAL CEMENT SYSTEM KIT
The Issue: During injection of cement, the water in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT
The Issue: During injection of cement, the water in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT
The Issue: During injection of cement, the water in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.