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 32241–32260 of 38,428 recalls
Recalled Item: Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety
The Issue: An investigation identified that the product was incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters
The Issue: Sterilmed, a division of Johnson & Johnson Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Perfecto 2 V Oxygen Concentrator The finished device is
The Issue: It was determined that a defective sieve bed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zeego systems
The Issue: A cable inside the C-arm systems may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArcPoint Labs 5 Panel Dip Drug Screen
The Issue: Ameditech is recalling the ArcPoint Labs Dip Drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microseal Augmented (20 degrees) Liner
The Issue: Incorrect dimension on four liners was detected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArcPoint Labs 10 Panel Dip Screen (BAR)
The Issue: Ameditech is recalling the ArcPoint Labs Dip Drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArcPoint Labs 10 Panel Dip Screen (OXY)
The Issue: Ameditech is recalling the ArcPoint Labs Dip Drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Mobile X-ray Systems used to take diagnostic radiographic exposures
The Issue: There is a potential for unintended and erratic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GMK Intramedullary Extension Rod 100 mm is a rod to
The Issue: Medacta has registered in its database 3 cases
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture
The Issue: CP Medical Inc. is recalling five lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body
The Issue: TriVascular has identified select lots of Ovation Prime
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MaxLock Extreme Mod-Foot Concave Reamer
The Issue: Incorrect sizing was being laser etched on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Bone Level Tapered Implant 04.1 mm RC
The Issue: Assembled with Narrow Connect (NC) transfer piece instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE /IMMULITE 1000 Systems COR Cortisol
The Issue: Customer complaints were received for positive bias reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External power supply adaptors that accompany Clinitek Status+ The Clinitek
The Issue: The external power supply for the Clintek Status
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External power supply adaptors that accompany Clinitek Status Connect System
The Issue: The external power supply for the Clintek Status
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External power supply adaptors that accompany Clinitek Status Power Supply
The Issue: The external power supply for the Clintek Status
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carescape Patient Data Module
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calcitonin ELISA Kit
The Issue: A potential issue with false high values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.