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 31361–31380 of 38,428 recalls
Recalled Item: nordicTumorEx 1.0 nordicTumorEx is an image processing software package to
The Issue: An error was discovered in the interpretation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trident PSL HA Solid Back 50 mm Includes Dome Hole
The Issue: Five customer complaints were received for the same
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number
The Issue: Certain lots have the potential for tip breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysio Max
The Issue: for composed images to be flipped before
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PF4 Concentrated Wash (10x)
The Issue: Some Lots of PF4 Concentrated Wash (10X) are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malleable C- Retractor
The Issue: failure and/or corrosion of the internal spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juno DFR X-ray system
The Issue: The system does not provide the appropriate audible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro...
The Issue: Creatinine kit C7539-150 contains Creatinine reagent R1 that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is
The Issue: Teleflex Medical has issued an advisory notification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MUM-1 (Multiple myeloma oncogene-1)
The Issue: Three lots of MUM-1 may not meet their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autopen Classic Automatic insulin delivery pen
The Issue: The dials in the Autopens are not working
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TASP) Tibial Articular Surface Provisional Shim
The Issue: for delay in surgery and/or ball bearings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Civco
The Issue: The product (wool wrist loop) was manufactured 7cm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast
The Issue: The IFU provided in the affected units of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Civco
The Issue: The product (wool wrist loop) was manufactured 7cm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The I-Cart is used to store
The Issue: The transformers installed on carts used for Richard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.