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

If no other syringes are available, doctors are urged to carefully monitor patients when the Chinese-made syringes are used, which may leak, break or cause other life-threatening complications

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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

AT&T Data Breach Class Action Claims Telecom Giant
AT&T Data Breach Class Action Claims Telecom Giant "Disregarded" Customer Financial Safety (Posted yesterday)

A Missouri woman is one of the latest person to file an class action claim over the AT&T data breach, after the telecom company admitted that hackers stole millions of customers' personal information and sold it on the internet.

Plaintiffs Oppose Phased Discovery Over Suboxone Tooth Decay Risks in MDL
Plaintiffs Oppose Phased Discovery Over Suboxone Tooth Decay Risks in MDL (Posted 2 days ago)

Plaintiffs say a federal judge should not waste time on a phased discovery plan requiring them to first prove Suboxone strips can cause tooth decay, saying the science is obvious and such a plan could delay resolution of hundreds of product liability lawsuits.