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 16361–16380 of 38,428 recalls
Recalled Item: Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
The Issue: leak in the balloon extension line. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HardyCHROM MRSA
The Issue: False Positive results due to the MSSA (methicillin-susceptible)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precision Xtra Blood Glucose & Ketone Monitoring System
The Issue: Instructions sent in a letter or in instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optium EZ Blood Glucose Monitoring System
The Issue: Instructions sent in a letter or in instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Precision H Blood Glucose and Ketone Monitoring System
The Issue: Instructions sent in a letter or in instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent
The Issue: Cordis has initiated a labeling correction for S.M.A.R.T
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent
The Issue: Cordis has initiated a labeling correction for S.M.A.R.T
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T....
The Issue: Cordis has initiated a labeling correction for S.M.A.R.T
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/ zeego Interventional Fluoroscopic X-Ray System
The Issue: In affected Artis zee floor Interventional Fluoroscopic X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Affinity
The Issue: Medtronic has identified an out of-specification condition exhibiting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eleganza 5 (AC powered adjustable bed)
The Issue: A component used within the side rail mechanism
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lamicel 10PK 10MM INTL
The Issue: Routine sterilization dose does not meet the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lamicel 20PK 5MM INTL
The Issue: Routine sterilization dose does not meet the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lamicel 20PK 3MM INTL Cervical dilator
The Issue: Routine sterilization dose does not meet the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion...
The Issue: Sterile barrier system may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with
The Issue: Nonfunctional key due to the potential for damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System
The Issue: When connected to the Mission Critical (MC) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIC Pro Clinical Information Center Central Station - Product Usage:
The Issue: When connected to the Mission Critical (MC) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Central Station - Product Usage: The intended use is
The Issue: When connected to the Mission Critical (MC) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea International Universal Counter Torque for use with the Pass
The Issue: Incompatible universal counter torque (A22020500) with the nut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.