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 9761–9780 of 38,428 recalls
Recalled Item: VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS
The Issue: Calibration disk Data Release Version (DRV) 6194 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EKOS Control Unit 4.0 console
The Issue: Consoles were shipped without an instruction for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Action Industries Inc. Disposable Instrument Pack
The Issue: Scissors contained debris
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Action Industries Inc. Port Access Kit
The Issue: The Port Access Kits were incorrectly labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System
The Issue: Abbott has identified potential performance issues for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BASIN SET
The Issue: Basin Set labeling error: components within the kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OneLIF Torque Limiting Adapter
The Issue: The torque limiting adapter may not stay locked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808
The Issue: Due to Indirect Decompression System devices exhibiting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Nexiva Closed IV Catheter System - Single Port REF
The Issue: During needle withdrawal, the tip shield may prematurely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic Sizer Set- sterilization tray and 6 individual sizers
The Issue: IFU was not provided with the Sizer Set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE Liberator 45
The Issue: An audit discovered some inconsistencies in weld penetration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE Liberator 20
The Issue: An audit discovered some inconsistencies in weld penetration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE Liberator 30
The Issue: An audit discovered some inconsistencies in weld penetration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE Liberator 45
The Issue: An audit discovered some inconsistencies in weld penetration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Model 4000 Syringe Infusion Pump
The Issue: for delay in sending Infusion Start Messages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PAJUNK Continuous Epidural Tray
The Issue: The tray contains a 2ml ampule of 0.75%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal...
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da
The Issue: staple deployment failure and device fragment generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.