FDA Issues Import Alert for Certain Chinese-Made Syringes, Due to Leaks and Other Defects

In response to potentially serious problems with Chinese-made syringes, which may fail to meet quality requirements and have been linked to performance issues, federal regulators have issued an import alert and a series of recommendations for healthcare professionals to reduce the risks associated with the syringes.

The U.S. Food and Drug Administration (FDA) announced the Jiangsu Shenli Medical Production Co. Ltd. syringe warning on April 10, advising healthcare providers and facilities to discontinue the use of all models of the manufacturer’s plastic syringes.

Consumers were first alerted to problems with the syringes in November 2023, when the agency announced that it was investigating reports of the plastic syringes breaking, leaking or causing other complications that suggested potential quality issues.

A syringe warning letter was officially issued by the FDA on March 18, indicating that there were multiple violations associated with the unapproved plastic syringes manufactured in China. These syringes have not obtained clearance or approval from the FDA for sale or distribution in the United States. These letters were sent to Medline Industries, LP and Sol-Millennium Medical, Inc., and Jiangsu Shenli Medical Production Co. Ltd.

Due to the problems with the plastic syringes, the FDA is warning facilities and health care providers to stop using them. However, if the syringes are absolutely needed, they can be used until new syringes are available, but the agency urges doctors to ensure the syringes are being monitored for leaks or other issues.

The FDA recommends that consumers check their plastic syringes for the manufacturer and attempt not to use any plastic syringes made in China. Glass syringes, pre-filled syringes, or syringes intended for oral or topical use are excluded from this investigation.

The supply and manufacturing capacity for plastic syringes produced in countries other than China appear to be sufficient to meet consumer demands, according to the FDA, including those domestically manufactured.

If consumers and healthcare providers encounter an issue with a syringe or any medical device, they are urged to report the incident using the MedWatch adverse event reporting system. Healthcare personnel at facilities subject to FDA’s user facility reporting requirements should follow their facility’s reporting procedures. For supply concerns regarding syringes or other devices, providers can reach out to the FDA to report medical device supply chain issues.

For other inquiries, contact the Division of Industry and Consumer Education (DICE) via email at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.