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 37541–37560 of 38,428 recalls
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1. System 1 base 100/120V. The
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSI Stealth 360-degree Orbital Atherectomy Device (OAD)
The Issue: CSI has initiated a recall on specific lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta 2 Bed. The Advanta 2 Bed is intended for
The Issue: During an evaluation of Advanta 2 siderail samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated...
The Issue: superDimension, Inc., is conducting a recall of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK
The Issue: Surgical kits and trays contain Stryker Hytrel Togas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is
The Issue: Multiple issues were identified with the GE Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA Satellite Automated Multi-Parameter Analyzer This system is a fully
The Issue: Following a single customer complaint that incorrect INR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent
The Issue: The recall was initiated because Carefusion has identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Echelon MRI System/Oasis MRI
The Issue: Hitachi discovered a software error with a feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Octane-C Cervical
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary
The Issue: Exactech, Inc. initiated a recall of Equinoxe Replicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AEM Disposable Electrodes
The Issue: Encision is performing a field correction to their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The 2.7mm Drilling Guide is a reusable instrument used in
The Issue: Integra' s quality system noted an adverse trend
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.