Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,621–1,632 of 2,908 recalls
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed.…
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be inte…
Lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone.…
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert.…
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert.…