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 25421–25440 of 38,428 recalls
Recalled Item: Monaco RTP System Product Usage: Used to make treatment plans
The Issue: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eclipse Hypodermic Needle
The Issue: BD is initiating a Product Advisory for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
The Issue: Higher than anticipated rate of fracturing due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Na+ Slides
The Issue: There is a potential for biased results to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Connect Diabetes Management App
The Issue: iOS and Android: Under certain conditions the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm
The Issue: Product complaints indicated that the part and lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Active Articulation ArComXL Polyethylene Bearings Active Articulation...
The Issue: Product complaints indicated that the part and lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxH 600 Coulter Cellular Analysis System
The Issue: Beckman Coulter has determined that additional clarification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN.
The Issue: Bard Access Systems announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCREW 02.7-12MM LOCKING
The Issue: Dimensional non-conformity of the thread on the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO SCREW 02.7-14MM LOCKING
The Issue: Dimensional non-conformity of the thread on the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9800. MDL Numbers: D222250
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOVIEW(R) SCREWS SET
The Issue: Dimensional non-conformity of the thread on the screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code:
The Issue: Bard Access Systems announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 Coulter Cellular Analysis System
The Issue: Beckman Coulter has determined that additional clarification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The OEC 9900 Elite mobile fluoroscopy system is designed to
The Issue: GE Healthcare Surgery announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker
The Issue: The product was not functioning as intended. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM
The Issue: Siemens Healthcare Diagnostics has determined that Dimension AMM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The
The Issue: Siemens Healthcare Diagnostics has determined that Dimension Vista
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.