🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
All Recalls
95,018 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Physio-Control
🏥 Medical Devices Class I - Dangerous
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
🏥 Medical Devices Class I - Dangerous
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
🏥 Medical Devices Class I - Dangerous
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
🏥 Medical Devices Class I - Dangerous
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
🏥 Medical Devices Class I - Dangerous
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
🏥 Medical Devices Class I - Dangerous
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
🏥 Medical Devices Class I - Dangerous
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
🏥 Medical Devices Class I - Dangerous
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
🏥 Medical Devices Class I - Dangerous
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Maquet Medical Systems USA
🏥 Medical Devices Class I - Dangerous
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.