Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 265–276 of 371 recalls
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior t…
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.