December 1, 2023- The U.S. Food and Drug Administration (FDA) issued a safety communication on November 30 informing consumers, health care providers, and health care facilities that the organization is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China.
The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
The FDA received information about quality issues associated with several Chinese manufacturers of syringes. We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.
Not all distributors are affected, according to a press release from BD, the FDA safety notice does not apply to BD syringes because the are manufactured in the United States.
For more information from the FDA, click here.