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 1–20 of 38,428 recalls
Recalled Item: EndoVive Safety PEG Kit
The Issue: Recall of kits which utilized ChloraPrep Triple Swabsticks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Owner's Booklets and Instructions for Use that are used with
The Issue: The system labeling (user manual and online labeling)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artelon FlexBand Dynamic Matrix
The Issue: Augmentation devices failed bacterial endotoxin testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Owner's Booklets and Instructions for Use that are used with
The Issue: The system labeling (user manual and online labeling)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Owner's Booklets and Instructions for Use that are used with
The Issue: The system labeling (user manual and online labeling)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artelon FLEXBAND TWIST .12 3.85x17mm HEX Anchor (Qty
The Issue: Augmentation devices failed bacterial endotoxin testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artelon FlexBand Plus & 41057
The Issue: Augmentation devices failed bacterial endotoxin testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Owner's Booklets and Instructions for Use that are used with
The Issue: The system labeling (user manual and online labeling)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Proton Beam Therapy System
The Issue: Software anomaly in the patient positioning system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Proton Beam Therapy
The Issue: Software anomaly in the patient positioning system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Campy CVA Medium 100/PK
The Issue: Customer complaints report low to no recovery of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA Liatest Free Protein S Product Name: STA
The Issue: The potential of out-of-range results and an underestimation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle
The Issue: Impactor handle may be missing cross-pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog
The Issue: Impactor handle may be missing cross-pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235
The Issue: It was identified that eh Universal Beam Triggering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Product Name: 21GA WINGED INF SET
The Issue: The potential for the needle tip to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Product Name: 21GA WINGED INFUSION
The Issue: The potential for the needle tip to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Product Name: BBraun Medical 21G X4.4CM
The Issue: The potential for the needle tip to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CHEMISTRY ANALYZER AU5800
The Issue: A delay in results may occur. When clinical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit:
The Issue: The instructions for use (IFUs) on specified Cardinal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.