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 16961–16980 of 38,428 recalls
Recalled Item: CEZANNE II TLIF Bullet-Tip Cage
The Issue: Reports received of the device fracturing during insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COMP RVRS Shoulder Baseplates
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMOD PORCOAT HA GLENTRAY
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BALL NOSE GUIDE WIRE 80CM
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Hip systems
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HA Pins (DFS HA Cort Screw)
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive RS Cleat CAP
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LT DISC ULNA - HA/PC
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HENNESSY LEFT CONST GLENOID HA
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Custom Products
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compress
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Copeland HA Resurfacing Head
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.0MM BALL NOSE GUIDE WIRE
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive HHR Tess Cleat
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GUIDE WIRE 2.2MM X 28IN
The Issue: Elevated levels of bacterial endotoxin and residual debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioEnvelope
The Issue: suture brittleness or breakage along the Envelope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large)
The Issue: suture brittleness or breakage along the Envelope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic
The Issue: Incorrect labeling on the products package. The label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
The Issue: need for device replacement - Elective Replacement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.