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 20721–20740 of 38,428 recalls
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2 Recalled by Stryker Neurovascular Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRSASelect
The Issue: Abnormal coloration of agar plates and the growth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRSASelect II
The Issue: Abnormal coloration of agar plates and the growth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCOS Modular Revision Hip System
The Issue: Two lots of the Echo BI-Metric Hip Stem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHO Bi-Metric Hip System
The Issue: Two lots of the Echo BI-Metric Hip Stem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0
The Issue: Products do not meet a tensile strength specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dermatone AN
The Issue: Devices may have a loose control bar, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Cardiac Control - Level 3
The Issue: The device is not suitable for the control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18")
The Issue: Products do not meet a tensile strength specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18")
The Issue: Products do not meet a tensile strength specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MRI Systems
The Issue: The latest on-site software version may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MRI Systems
The Issue: The latest on-site software version may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MRI Systems
The Issue: The latest on-site software version may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the
The Issue: GE Medical Systems has discovered a small area
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G8 Automated HPLC Analyzer: HLC-723G8-ST
The Issue: HbAE is known to interfere with the HbA1c
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Radiation Therapy Treatment Planning System
The Issue: The firm has learned that some RayStation/RayPlan users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.