🏥 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.
All Recalls
95,114 total recalls in our database
🏥 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
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in out of specification R3 Acetabular Shells
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
🏥 Medical Devices Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
🏥 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
Distributed to the field without having completed design history files or design transfer activities
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
🏥 Medical Devices Class I - Dangerous
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
🏥 Medical Devices Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Biocare Medical
🏥 Medical Devices Class I - Dangerous
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.