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 31141–31160 of 38,428 recalls
Recalled Item: Philips DuraDiagnost X-Ray system
The Issue: Improper installation of Tube arm, and Wall stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap with Povidone-Iodine Solution
The Issue: Product may have separating or protruding sponges
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Caps for capillary 140/175 uL
The Issue: Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Caps for capillary 50/60 uL
The Issue: Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Caps for capillary 100 uL
The Issue: Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use
The Issue: When using the MAKOplasty partial knee Arthroplasty application,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemLock Long Hex Driver
The Issue: The Gemlock Long Hex Driver may not fit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FORUM Archive and Viewer
The Issue: Software defect in the FORUM Viewer versions 3.1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo
The Issue: A system freeze-up of the Merge Hemo system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens LANTIS Oncology Information System Servers
The Issue: There is a potential safety risk when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
The Issue: A device malfunction may cause the biopsy needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC ACE Curved Shears Instructions for Use
The Issue: Internal labeling review found that the IFU for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC ACE Curved Shears Instructions for Use
The Issue: Internal labeling review found that the IFU for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquarius iNtuition Client Viewer. Findings Workflow module
The Issue: Software anomaly related to RECIST1.1 target lesion evaluation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM
The Issue: Drug products contained within the kits may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Sterile Double DIN to DIN "Y" Connector
The Issue: A customer relayed a complaint of a leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Systems Drug Calibrator I
The Issue: Incorrect calibrator lot values were assigned for ADVIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Closed Suction System for Adults
The Issue: Defect: A hole or crack was found which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Closed Suction System for Adults
The Issue: Defect: A hole or crack was found which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Wet Pak
The Issue: Defect: A hole or crack was found which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.