Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Firm noted an increase in customer reports of leaks.
All Recalls
95,018 total recalls in our database
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FUJIFILM Healthcare Americas
🏥 Medical Devices Class I - Dangerous
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
QIAcube Connect MDx, Model No. 9003070
Qiagen Sciences
🏥 Medical Devices Class I - Dangerous
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
ICU Medical
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Surpria: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas
🏥 Medical Devices Class I - Dangerous
Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
🏥 Medical Devices Class I - Dangerous
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Mako Surgical
🏥 Medical Devices Class I - Dangerous
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
🏥 Medical Devices Class I - Dangerous
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
🏥 Medical Devices Class I - Dangerous
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
🏥 Medical Devices Class I - Dangerous
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Cityscape Travel Jogger Strollers, Model TJ75B12A
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The parking brake on the strollers can fail, posing fall and injury hazards to children.
Model Year 2022 Cervélo R5 and Caledonia-5 bicycles and Cervélo ST31 LT replacement stems
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The handlebars on the bicycles can slip in the stem and cause the rider to lose control, posing a fall hazard.