Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
27,577 detailed records are currently available in this category.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment…
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
Potential risk for helium gas inside the MR examination room during a magnet quench
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
The integrity of the sterile packaging is potentially compromised.
Potential risk for helium gas inside the MR examination room during a magnet quench
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Potential risk for helium gas inside the MR examination room during a magnet quench
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header.…
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Potential risk for helium gas inside the MR examination room during a magnet quench
Potential risk for helium gas inside the MR examination room during a magnet quench
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header.…
Potential risk for helium gas inside the MR examination room during a magnet quench
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Update to cooler-heater cleaning instructions.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Update to cooler-heater cleaning instructions.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
