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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.
Products labeled as sterile were distributed, but may not have been sterilized.