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 11161–11180 of 38,428 recalls
Recalled Item: The Optima Coil System consists of an implantable embolization coil
The Issue: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRA SURFIX ALPHA Screwdriver Torx 10
The Issue: The affected screwdrivers are out of specification and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eCareManager version 4.2.1
The Issue: eCareManager (eCM) Sentry Score software not approved for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY
The Issue: The firm found immunoassay products used to detect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan- designed for treatment planning and analysis of...
The Issue: If a new primary image set is selected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exeter V40 Cemented Hip (150mm) Stem
The Issue: There is a potential label mix between certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exeter V40 Cemented Hip (125mm) Stem
The Issue: There is a potential label mix between certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
The Issue: Micro-Kill Bleach Wipes contain out of specification (low)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDPOR Titan OFW - MTB - Right - 1.0mm
The Issue: Inside the packaging of one reported item a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X060-0270
The Issue: The proximal opening of the inserts exhibit an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Spectrum IQ Infusion Pumps
The Issue: There is the potential for reduced or non-delivery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YOUNG DH Dry Heat Indicators
The Issue: The Dry Heat Indicator Labels packaging may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
The Issue: There is the potential for reduced or non-delivery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bronchial Microbiology Brush
The Issue: The labeling for the Microbiology Brush identifies the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celltrion DiaTrust COVID-19 Ag Rapid Test
The Issue: The affected lot was placed under quarantine in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer
The Issue: Conductive Cannula Reducer metal tip may get dislodged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Mobile Lifts: Primarily intended for use in nursing homes
The Issue: Missing bushing on Liko M220 and M230 causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220
The Issue: Missing bushing on Liko M220 and M230 causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.