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 14261–14280 of 38,428 recalls
Recalled Item: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator
The Issue: Blood collection tubes experienced an issue with separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens epoc BGEM Test Card-In vitro diagnostic device for the
The Issue: Sporadically inconsistent discrepant (low bias) glucose results on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended
The Issue: Label has the incorrect size for the tracheotomy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Albumin Gen.2
The Issue: Roche has confirmed customer complaints of low quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tina-quant Complement C4 ver.2
The Issue: Roche has confirmed customer complaints of low quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Xtreme (PTCA Balloon Dilation Catheter)
The Issue: Labeling discrepancy for the Rated Burst Pressure (RBP)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLVE STEM 8.5MM Model # 496S085
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol
The Issue: Due to alkaline phosphatase (ALP) associated interference causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rashkind Balloon Septostomy Catheter
The Issue: Subsequent failure of catheters in the field and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rashkind Balloon Septostomy Catheter
The Issue: Subsequent failure of catheters in the field and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge -
The Issue: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rashkind Balloon Septostomy Catheter
The Issue: Subsequent failure of catheters in the field and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM HER-2/neu (H2n) assay
The Issue: Siemens confirmed that the Upper Limit of Normal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquas PowerFlow Tube Set - Product Usage: The device delivers
The Issue: The product design incorporating a motor driven impeller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Radiology Solutions 14.0
The Issue: Software defect which may potentially result in one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK
The Issue: Internal testing at the supplier, revealed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32
The Issue: Internal testing at the supplier, revealed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32
The Issue: Internal testing at the supplier, revealed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm)
The Issue: Opticross 35 Peripheral Imaging Catheter is being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health"...
The Issue: The third-party brand latex micro surgical gloves packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.