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All product recalls associated with Stellate Systems.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America.
Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
External tubing may separate during use, allowing blood loss.
External tubing may separate during use, allowing blood loss.
Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.
External tubing may separate during use, allowing blood loss.
Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
External tubing may separate during use, allowing blood loss.
Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
External tubing may separate during use, allowing blood loss.
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.
Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.
Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. There is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.
Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
Needles separate from the barrel of the syringes.
Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
This recall involves women's sling-back, pointed-toe shoes sold under the George brand. The shoes were sold in three colors, black, gray and purple, and in sizes 5 ½ to 11.