Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 73–84 of 123 recalls
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark.…
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 inste…
Required inspections were not performed on finished product prior to release and distribution.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.