💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as glass
All Recalls
92,900 total recalls in our database
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
Bristol-Myers Squibb Company
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility.
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline Industries
🏥 Medical Devices Class I - Dangerous
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
🏥 Medical Devices Class I - Dangerous
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
UIH Technologies
🏥 Medical Devices Class I - Dangerous
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
UIH Technologies
🏥 Medical Devices Class I - Dangerous
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
🏥 Medical Devices Class I - Dangerous
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
SM_40HF_B_D_VIR3, Mobile X-ray system
SEDECAL SA
🏥 Medical Devices Class I - Dangerous
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.