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 10401–10420 of 38,428 recalls
Recalled Item: Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory
The Issue: A forced shutdown of one of the processors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker INFINITY Resect Guide for INBONE Talus
The Issue: The instrument is incorrectly color coded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DVR Anatomic
The Issue: One lot of DVRASL plates were incorrectly etched
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
The Issue: Under certain circumstances, the mounting screws may loosen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Aisys CS2 Anesthesia System
The Issue: There is a potential reversal of the O2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 9B SP1. For radiation treatment planning.
The Issue: An issue with propagation of treatment course information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic
The Issue: Discrepant (low bias) pO2 results, could be an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventana HE 600 System
The Issue: There is a potential for fluid leak inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Laser System
The Issue: The LAS-100 Laser system may detect an inoperable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peak Universal Bond Self-Etch Bottle Kit
The Issue: SE primer may be missing some or all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal
The Issue: The product was potentially exposed to below-recommended storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xhibit Telemetry Receiver
The Issue: Software related alarm escalation defect occurs after approximately
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuRx Diaphragm Pacing System (NeuRx DPS)
The Issue: Firm has revised labeling to consistently call out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GreenLight HPSEA Laser Fibers
The Issue: Several complaints were received for the affected lot;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients
The Issue: Alternate Bottle Caps labeled with "Sealed for your
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients
The Issue: Alternate Bottle Caps labeled with "Sealed for your
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaviCare Nurse Call/Voalte Nurse Call
The Issue: An issue has been identified with Phillips (Emergin)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Positron Emission Tomography and Computed Tomography System
The Issue: The wireless VSM module of a mobile PET/CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis
The Issue: Due to receiving complaints related to broken (cracked)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEAD 3387S-40 STIMLOC DBS
The Issue: There are a small number of units of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.