Sponsored By

Merit Medical Recalls Plastic Syringes Made in China

The recall is a direct response to FDA’s earlier recall of unauthorized plastic syringes from China, which are used in multiple kits marketed by Merit Medical.

Norbert Sparrow

June 17, 2024

1 Min Read
medical plastic syringe in packaging
Olga Trofimova/iStock via Getty Images

The FDA announced on Friday a recall of medical plastic syringes by Merit Medical Systems initiated in direct response to the agency’s recall of unauthorized plastic syringes produced by China-based manufacturer Jiangsu Shenli Medical Production Co Ltd. The affected syringes are included in multiple kits sold by Merit Medical.

FDA first reported that it was looking into faulty medical syringes on Nov. 20, 2023. The syringes reportedly were not consistently delivering the correct dose of medication.

In an update on March 19, 2024, the agency said it had issued warning letters to syringe manufacturer Jiangsu Shenli in China, along with Medline and Sol-Millenium Medical that market and distribute the syringes in the United States. A number of quality issues were raised including leakage, breakage, and the aforementioned dosage problems.

In the March 2024 update, FDA recommended transitioning away from some plastic syringes made in China that are used to inject fluids into the body or to withdraw them. The recommendation does not affect glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA stressed at the time.

On May 14, 2024, the Biden administration announced a plan to increase tariffs on imports from China. Some medical products are included in the hikes, notably syringes and needles, which will see tariffs rise from 0% to 50% this year. Although the overall tariffs are levied in response to China's unfair trade practices, the White House mentioned the quality issues affecting the plastic syringes in its announcement.

Related:Schott Pharma to Build Plastic Syringe Manufacturing Plant in North Carolina

About the Author(s)

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.


Sign up for the PlasticsToday NewsFeed newsletter.

You May Also Like