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 1101–1120 of 38,428 recalls
Recalled Item: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER
The Issue: It was determined there is the potential of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM
The Issue: It was determined there is the potential of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS
The Issue: It was determined there is the potential of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS
The Issue: It was determined there is the potential of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar
The Issue: packaging issue that could compromise the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Veritor Connect Software
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD EpiCenter Microbiology Data Management System
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC Blood Culture System
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC Blood Culture System
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET ZipTight
The Issue: There is a potential for a missing slotted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX System
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix M50 Instrument
The Issue: Product service credentials used by some BD technical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The
The Issue: Due to a software error code that crashes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assay: IMMULITE 2000 Intact PTH
The Issue: The potential for falsely depressed Intact PTH patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virata Preassembled Polyaxial Screw
The Issue: Polyaxial screws do not meet performance standards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: Beckman Coulter has confirmed a software anomaly on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500i Clinical Analyzer Modules
The Issue: Beckman Coulter has confirmed a software anomaly on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300
The Issue: Complaint identified issue with AI surgical planning software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity hq Analyzer Product Name: Alinity hq Analyzer
The Issue: Software issue for hq analyzer results in system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM
The Issue: Firm has received complaints regarding Anti-Reflux Valve (ARV)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.