HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
All Recalls
95,038 total recalls in our database
💊 Drugs Class I - Dangerous
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Assurance Infusion
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
🏥 Medical Devices Class I - Dangerous
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
🏥 Medical Devices Class I - Dangerous
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
CARESCAPE Respiratory Module E-sCAiOV
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Airway Gas Option N-CAiO
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
🏥 Medical Devices Class I - Dangerous
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
🏥 Medical Devices Class I - Dangerous
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
CARESCAPE Respiratory Module E-sCAiO
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
Physio-Control
🏥 Medical Devices Class I - Dangerous
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
🏥 Medical Devices Class I - Dangerous
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.
🏥 Medical Devices Class I - Dangerous
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
🏥 Medical Devices Class I - Dangerous
Temperature deviation did not meet release specifications
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Trilliant Surgical
🏥 Medical Devices Class I - Dangerous
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Physio-Control
🏥 Medical Devices Class I - Dangerous
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
🏥 Medical Devices Class I - Dangerous
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..