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 19401–19420 of 38,428 recalls
Recalled Item: NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The
The Issue: Software defect: For Helical scan with ClearView function,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice
The Issue: Software defect: For Helical scan with ClearView function,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more
The Issue: False resistant results for Streptococcus anginosus and Streptococcus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage:
The Issue: Inspection process at the manufacturer found nonwoven material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Smooth Guide Wire - Bullet Tip
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail¿ System - Tear Drop Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL Trypticase Soy Agar with 5% Sheep Blood
The Issue: a portion of a single lot was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail¿ System - Tear Drop Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Pressure Sentinel¿ Intramedullary Reaming System
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Humeral Guide Wire - Ball Tip
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail¿ System - Tear Drop Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Pressure Sentinel¿ Intramedullary Reaming System
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail¿ System - Tear Drop Guide Wire
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip
The Issue: Various Trauma Guide Wires- creases in the sealing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow
The Issue: It is possible that the packaging of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Knee System -PS Open Box Femoral Left
The Issue: Label on the outer carton or the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.