Issues With Syringes Made in China ‘More Widespread’ Than Expected: FDA

The FDA has advised Americans against using plastic syringes manufactured in China.

The White Oak campus of the U.S. Food and Drug Administration (FDA) in Silver Spring, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration (FDA) has advised Americans to not use plastic syringes made in China, as further investigation shows that the products’ problem is “more widespread” than expected.

The FDA announced in November 2023 that it was looking into reports of leaks, breakages, changes of dimensions, and other quality problems with plastic syringes manufactured in China. The agency was conducting further investigations along with federal partners and “as necessary, may prevent syringes made in China from entering the United States.”

On March 19, the health regulator stated that it had issued warning letters to Jiangsu Shenli Medical Production Co. Ltd, a syringe manufacturer based in Zhejiang Province, China, along with Medline Industries and Sol-Millenium Medical, two U.S.-based companies that market and distribute China-made syringes. The FDA accused the three companies of failing to meet quality requirements, saying they were involved in selling or distributing China-made syringes that “have not been cleared or approved by the FDA” for use in the United States.

Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, said in a statement that the agency has inspected facilities for Medline Industries and Sol-Millennium Medical, examined and detained products at borders, tested syringes, and worked with other applicable manufacturers to address the issue.

“Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known,” he said.

The FDA recommends that patients, health care providers such as hospitals, and suppliers “immediately transition away” from using plastic syringes manufactured by Jiangsu Caina Medical and Jiangsu Shenli Medical Production, unless the use is “absolutely necessary.”

For other brands of syringes, the FDA suggests checking where the products are manufactured and, if possible, consider using products made outside of China.

The agency noted that the issues don’t extend to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

The probe came after changes made to the syringe dimensions during production, which led to recalls and complaints registered to the health regulator about syringes made at various manufacturing sites in China.

The potential device failures could affect health providers’ ability to deliver the correct dose of medication when used alone or with other medical devices, such as infusion pumps, the health regulator stated, noting that it would work with manufacturers to ensure that corrective actions were taken.

The Epoch Times reached out to Jiangsu Shenli Medical, Sol-Millennium Medical, and Medline Industries for comment but didn’t receive replies by press time.

Call for Boosting Domestic Medical Supply

Safety issues related to China-made syringes have led to a renewed call to increase domestic medical supplies.

“Unfortunately, problems with imported medical supplies aren’t rare. It is harder for U.S. regulators, like the FDA, to inspect foreign manufacturers. That means it’s impossible to hold these imported products to the same quality and safety standards as domestic products,” Sens. Pete Ricketts (R-Neb.) and Richard Blumenthal (D-Conn.) wrote in a recent op-ed published on RealClearHealth.

“In fact, the last time the agency inspected a Chinese hypodermic device manufacturing facility was in 2018. The FDA recently issued an advisory informing consumers of these potential syringe failures. While this is a good first step, we must do more to protect Americans’ health.”

The senators noted that four out of six needle and syringe manufacturing facilities in the United States shut down in 2023.

However, U.S. reliance on medical supplies from China and other countries has grown. According to the senators, 40 percent of syringes and needles used in the United States are imported, compared to 15 percent in 2018.

“Without a resilient domestic supply chain for medical supplies, we risk our nation’s crisis response, and the health of our citizens,” they wrote. “The most effective way to ensure the quality of these products is to manufacture them in the U.S.

“If we don’t change course soon, we risk losing the last of our syringe manufacturing facilities, which would make the United States largely reliant on China—a mistake we can’t afford to make.”

Reuters contributed to this report.