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 9881–9900 of 38,428 recalls
Recalled Item: STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated
The Issue: Packages may contain a PS-1 cutting edge needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allen Advance Table
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allen Life Assist Beach Chair
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Flex Polar Head Positnr-Device Only
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beach Chair Clamp
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci X (IS4200) and Xi (IS4000) systems
The Issue: Inadvertent energy delivery from surgical system instrument if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex MP Port Titanium Low Profile Implanted Port with 5F
The Issue: Printed Instructions for Use (IFU) not shipped with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno
The Issue: Siemens has become aware of three potential software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of
The Issue: An unapproved adhesive used to manufacture the accumulator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Lithium (Li)
The Issue: for falsely elevated LITH_2 and Li results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Lithium_2 (LITH_2)
The Issue: for falsely elevated LITH_2 and Li results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP software of the Ivenix Infusion System (IIS)
The Issue: Retroactively reported correction from 2022: A software defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400
The Issue: Blister package had an unsealed edge compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berkeley VC-10 Vacuum Curettage System
The Issue: Update to the Instruction for Use (IFU): Olympus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun CARESITE Port Access Kit w/Tegaderm
The Issue: The kits were incorrectly labeled with an extended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESITE SMALLBORE EXT SET T-PORT 5 IN.
The Issue: The extension set has a high probability of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULTRASITE US04TL Smallbore T-Port Extension Set
The Issue: The extension set has a high probability of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Tube Sodium Fluoride: 100 mg
The Issue: The affected product contains isobutylene which has recently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extension Set
The Issue: The extension set has a high probability of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male
The Issue: Sterile extension sets were distributed without an expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.