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 14101–14120 of 38,428 recalls
Recalled Item: Genesis (GII) - Product Usage: designed for use in patients
The Issue: The anterior locking detail does not meet its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended
The Issue: There is a software problem which affects the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow Sensor Service Part
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A Li-Gator Single Use Laparoscopic Clip Applier
The Issue: Device malfunction causing the applier to jam, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9100c NXT system - Product Usage: Device is licensed and
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow Sensor Service Part
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow Sensor Service Part
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is
The Issue: Flow sensors could have damaged tubes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOM Disposable Surgical Gowns/Medical Gowns
The Issue: Medical gowns distributed to customers did not include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen
The Issue: Instructions for use in the package insert for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-i Ventilator
The Issue: A potentially shorter than specified nebulizer connector may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MeritMedical Cultura Flex Swab
The Issue: The flocked tip of the 100mm swab may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Cultura Collection and Transport System
The Issue: The flocked tip of the 100mm swab may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Cultura Collection and Transport System
The Issue: The flocked tip of the 100mm swab may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.