Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
95,102 total recalls in our database
Fisher Diagnostics
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Terumo Cardiovascular Systems
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Qiagen Sciences
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
The potential for cracks forming in the breathing circuit hose.
Medtronic Neuromodulation
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Stryker
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Stryker Spine
Potential for the gold unlock button to separate from the inserter.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
Stryker Spine
Potential for the gold unlock button to separate from the inserter.
Ethicon Endo Surgery
Identified curing issues with the silicone during the needles manufacturing process.
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Ethicon Endo Surgery
Identified curing issues with the silicone during the needles manufacturing process.
The potential for cracks forming in the breathing circuit hose.
Cordis US
product mix-up; Vascular stent labeled as one size but contains a different size.