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 25041–25060 of 38,428 recalls
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Video Duodenoscope These instruments are intended to provide optical...
The Issue: Pentax initiated a field correction/safety alert for two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Efficia CMS200 Central Monitoring System
The Issue: The monitor may not alarm appropriately for a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Strata II / Strata NSC Valves (includes Burr Hole
The Issue: Medtronic Neurosurgery initiated a recall after receiving five
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5
The Issue: A portion of this lot of blood collection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is
The Issue: The End-Tidal CO2 (EtCO2) reading can intermittently show
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use
The Issue: The End-Tidal CO2 (EtCO2) reading can intermittently show
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with
The Issue: Indications for use are not cleared or approved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compressible Limb Therapy System (Leg Cuffs
The Issue: Distribution of unapproved devices with incorrect air compression
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Morning Life
The Issue: Distribution of unapproved devices with incorrect air compression
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051
The Issue: The product has the potential to be non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway
The Issue: Labeling error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LIFEPAK 1000 defibrillator is intended for use by personnel
The Issue: The firm has received complaints that the LIFEPAK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InterFuse Tail Traction Tool
The Issue: Fit issues have been identified with the Tail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GrebSet Micro-Introducer Kit
The Issue: Four Lots of GrebSet Micro-introducer Kits, model 7941,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15 Monitor
The Issue: The firm has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream DRX-Revolution Mobile X-Ray System
The Issue: The firm received a complaint alleging that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.