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 36061–36080 of 38,428 recalls
Recalled Item: GemStar Pump - Battery Product Usage: The GemStar Pump is
The Issue: Battery level lower then 2.4 volts results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glow 'N Tell 20 cm Tape: 1100-00 (100 strips)
The Issue: Devices were not sealed correctly during the manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Ojemann Cortical Stimulator
The Issue: If the headphone jack is in use during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system
The Issue: There was an occurrence where the patient case
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: The proximal and distal pressure sensor calibration can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: The proximal and distal pressure sensor calibration can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot...
The Issue: Insight Instruments, Inc., Stuart, FL is recalling M.I.S
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitrea¿ CT Brain Perfusion made available in various configurations under
The Issue: Vital Images, Inc. (Vital Images) received one report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea...
The Issue: Vital Images has made a decision to perform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical
The Issue: Revised instructions for users of the da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System
The Issue: Revised instructions for users of the da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACIST Medical Systems Inc. The ACIST Angiographic Injection System is
The Issue: ACIST Medical Systems is issuing a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV
The Issue: Software design error in IMPAX CV 7.8 SU3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound
The Issue: Baseline pulmonary capillary wedge (PCW) pressure values from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rev E PedFuse Return Screw Inserter
The Issue: Inserters have a set screw that fixes a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products PHBR (Phenobarbital) Slides
The Issue: Ortho Clinical Diagnostics (OCD) received customer complaints of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Oxford Partial Knee
The Issue: Biomet part # 506076, lot 928182 was received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae
The Issue: Two unsealed pouches were found at an Edwards'
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precise Treatment Table. To be used as part of radiation
The Issue: The Column rotation can accidentally be moved to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of
The Issue: This recall is being initiated because the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.