FDA alerts to potential failures of plastic syringes manufactured in China

Following an analysis of collected data, the FDA is warning consumers and healthcare providers of possible device failures (including leaks and breakages) in plastic syringes manufactured in China.

Designed to inject fluids into, and withdraw fluids from, the body, syringes are used in multiple clinical and home health settings. They are sometimes used with infusion pumps to deliver a controlled amount of fluids into the body.

Based on information it has gathered about quality issues connected with a number of the syringes produced by Chinese manufacturers, the agency said it has reason to believe the devices may not be perform consistently or with sufficient quality.

As the FDA continues to evaluate these plastic syringes, consumers, healthcare providers and facilities are advised to:

  • Review the labeling or outer packaging of syringes in use or in inventory and take note of the manufacturing location.
    • In the event that the information is not readily available, contact the device supplier or the group-purchasing organization.
  • If possible, use plastic syringes that were not made in China.
    • Consumers should note that to date of the FDA communication, the recall does not cover glass syringes, pre-filed syringes, as well as syringes associated with oral or topical purposes.
  • In the event that only plastic syringes manufactured in China are available, the syringes may continued to be used as needed until alternative syringes can be made available.
    • Use of the plastic syringes under these circumstances should be closely monitored for any leaks, breaks, or other issues.

At the time of the announcement, the FDA said it is collaborating with federal partners to assess the quality of the test syringes in question. It has plans to partner with manufacturers in order to assess where corrective actions are needed and to prevent the affected syringes from entering the U.S.

As the FDA continues to monitor the problems associated with the manufacture of these syringes, consumers and healthcare providers are asked to report any related problems to the agency’s MedWatch Voluntary Reporting Form and through protocols established by facilities subject to the FDA’s user facility reporting requirements.


If you have suffered an adverse health event that can be traced to a compromised or defective plastic syringe, we would like to help you pursue fair compensation. Our experienced attorneys at TruLaw are personally motivated in helping people like you hold negligent parties accountable and fight for the best outcome. Connect with us online or take our free Instant Case Evaluation ℠ to learn more.