Class I - Dangerous
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Class I - Dangerous
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Sky Medical Supplies and Equipments
Class I - Dangerous
Distributed COVID test kits without emergency use authorization.
Class I - Dangerous
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Class I - Dangerous
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
IOLMaster 700
Carl Zeiss Meditec AG
Class I - Dangerous
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Class I - Dangerous
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Class I - Dangerous
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Class I - Dangerous
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates