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 20461–20480 of 38,428 recalls
Recalled Item: VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
The Issue: The recalling firm determined that biased results may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111)...
The Issue: The recalling firm determined that biased results may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
The Issue: The recalling firm determined that biased results may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow XTP Straight Full Set
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow Catheter Full Tray
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peg Fully Threaded
The Issue: A size 22mm threaded peg was found in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow Double Lumen Catheter Only/Catheter Set
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Lumen CRRT/ABP Catheter Set
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow IJ Full Tray
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DUO FLOW DOUBLE LUMEN CATHETER
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow XTP Straight Full Set
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DUO FLOW CUSTOM TRAYS
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set
The Issue: The suture wings have the potential to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: power cord for: (a) AMIA Automated PD Cycler
The Issue: There were instances where the power cord socket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POM Procedural Oxygen Masks
The Issue: Complaints were received on the product, such as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CREA Slides
The Issue: The slides did not meet the current claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P400 PREM U/M 18FR TMPSNS
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 400mL
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.