Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Date Issued: November 30, 2023

The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

The FDA received information about quality issues associated with several Chinese manufacturers of syringes. We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.

Potential Syringe Failures

To date, the FDA is aware of quality issues from recent syringe recalls, Medical Device Reports (MDRs), and additional complaints about syringes made at various manufacturing sites in China. Quality issues reported have included leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. These quality issues may affect the performance and safety of the syringes including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.  

Report any issues with syringes to the FDA