Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 913–924 of 2,908 recalls
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples.…
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated to…
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer…
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimate…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…