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 35601–35620 of 38,428 recalls
Recalled Item: STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA
The Issue: Under specific conditions, there is an unlikely potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters
The Issue: Bard Peripheral Vascular (BPV) has confirmed that some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA
The Issue: Under specific conditions, there is an unlikely potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MC-500 Multicolor Laser Photocoagulator using software version 2.20....
The Issue: Retrospective review found that a Engineering Change Order
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Service Replacement 0-Ring. Used in as a service part
The Issue: Incorrect rubber nitrile O-rings distributed instead of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is
The Issue: The outer sleeve would not fit over the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIA Medical Collection Bag
The Issue: International Biomedical has received reports of interference between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMICUS Exchange Kit
The Issue: Fenwal has initiated a voluntary Urgent Product Recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYRUS ACMI
The Issue: lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the
The Issue: Failure to submit a premarket submission and gain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the
The Issue: Failure to submit a premarket submission and gain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViSi Mobile Chest Sensor (3 lead-wire ECG
The Issue: Sotera Wireless, Inc. is recalling the ViSi Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViSi Mobile Monitor
The Issue: Sotera Wireless, Inc. is recalling the ViSi Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Swift Mobil shower chair
The Issue: Etac is voluntarily conducting a field correction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sovereign¿ Compact Phacoemulsification System
The Issue: Abbott Medical Optics Inc. (AMO) initiated this Urgent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile...
The Issue: This is a recall expansion from the 2010
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile...
The Issue: This is a recall expansion from the 2010
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BC Hammock Mesh Sling (Medium)
The Issue: The product does not meet the firm's size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BC Hammock Mesh Sling (Small)
The Issue: The product does not meet the firm's size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BC Hammock Mesh Sling (Large)
The Issue: The product does not meet the firm's size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.