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All product recalls associated with Axya Medical.
Total Recalls
1000
Past Year
1000
Class I (Serious)
127
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.
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
This recall involves 30-inch-long link necklaces with a spinning wheel pendant. The wheel pendant, designed to resemble car's spinning tire rim, has rhinestones attached to the front, a silver base and measures 2¾ inches in diameter. The item has a clear plastic hang tag with a UPC code of 0 97138 68502 5.
Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered
Inaccurate anatomical measurements when using the optional SmartMask feature
Inaccurate anatomical measurements when using the optional SmartMask feature
Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.
Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Surgical manual lacks information required as a condition of the 510(k) approval.