CDRH New Update

CDRHNew

Date: July 24, 2017

The following new items were added to the CDRH web pages on July 21, 2017. Previous items can be found on the CDRHNew Page.

• Class I Medical Device Recall: Oscor Recalls ATAR Reusable and Disposable Extension Cable(s) Due to Risk of Cable Separation from Connector
• Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication
• Class I Medical Device Recall: Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use