March 21, 2024


The agency advises U.S. suppliers, consumers, and healthcare organizations to cease using plastic syringes from two Chinese manufacturers immediately. Director Jeff Shuren stated that after further evaluation, quality issues are more widespread than initially known. Inspections revealed violations related to the sale and distribution of unauthorized syringes and breaches of quality system regulations. The FDA urges transitioning away from these syringes and avoiding other plastic syringes from China if possible. Ongoing investigations include facility inspections, border device checks, lab testing, and more. The FDA expects the recipients of the warning letters to address the violations promptly.