December 5, 2023

FDA issues safety notice for syringes made in China

Editor's Note

The US Food and Drug Administration (FDA) issued a safety notice on November 30 regarding quality concerns related to several Chinese manufacturers of syringes. The FDA is evaluating these devices for potential problems, including leaks, breakages, and the presence of particles in the syringes. 

According to the safety notice:

  • The FDA received syringe recalls, Medical Device Reports, and complaints related to syringes made at sites in China that have included leaks and breakage and could impact their ability to deliver the correct dose of medication.  
  • The agency is working to test Chinese-made syringes and is working with manufacturers to ensure corrective actions are taken. 
  • The FDA may restrict these syringes from entering the US, if required.
  • At this time, the safety notice does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

The FDA is currently advising healthcare facilities to check their syringes for manufacturing location; consider not using syringes made in China, and/or to closely monitor these syringes for any leaks or breakage and report such findings immediately to the FDA. 


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