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 19181–19200 of 38,428 recalls
Recalled Item: MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in
The Issue: If the head mount knob is not properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2
The Issue: Kits labeled as containing a 40 cm PICC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2
The Issue: Kits labeled as containing a 40 cm PICC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 AST-N351 Test Kit
The Issue: False Positive ESBL Phenotype
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology
The Issue: There is a potential that Wedge IDs were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureStep(TM) FOLEY TRAY SYSTEM
The Issue: for urine leakage around the vent on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with
The Issue: Unintentional shifting of the tip insulation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epix Electrosurgical Probes with Smoke Evacuation
The Issue: Unintentional shifting of the tip insulation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 1500
The Issue: When the Millipore Water Purification Module Progard Pretreatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500
The Issue: When the Millipore Water Purification Module Progard Pretreatment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 Product Usage: The Proton Therapy System - Proteus
The Issue: There is a risk of detachment of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended
The Issue: for the software on Automated PD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMIA Automated Peritoneal Dialysis System Product Usage: It is intended
The Issue: for the software on Automated PD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic
The Issue: Negative bias results when using VITROS VALP Reagent,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U by Kotex¿ Sleek¿
The Issue: for tampon to come apart upon removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U by Kotex¿ Sleek¿
The Issue: for tampon to come apart upon removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U by Kotex¿ Sleek¿
The Issue: for tampon to come apart upon removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U by Kotex¿ Sleek¿
The Issue: for tampon to come apart upon removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic
The Issue: No results/incorrect results due to failure of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aperio CS2 CE IVD scanner instrument
The Issue: The incorrect sensor was used in the assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.