🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
🏥 Medical Devices Class I - Dangerous
There is potential for the plastic optical tip to become detached from the metal shaft.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
INARI MEDICAL
🏥 Medical Devices Class I - Dangerous
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
🏥 Medical Devices Class I - Dangerous
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
🏥 Medical Devices Class I - Dangerous
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
🏥 Medical Devices Class I - Dangerous
Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems
Becton, Dickinson and Company, BD Biosciences
🏥 Medical Devices Class I - Dangerous
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
🏥 Medical Devices Class I - Dangerous
False positive results due to potential contamination of reagent.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities