Arkray is recalling certain test strips due to inaccurate blood sugar readings. Source: The GMP Letter

Sientra is planning to return all of its medical devices — including breast implant products — to the U.S. market starting March 1. Source: The GMP Letter

Dräger is recalling 117 emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Source: The GMP Letter

Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Source: The GMP Letter

The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Source: The GMP Letter