Months after the FDA told healthcare facilities to avoid plastic syringes made in China because of leaking issues, four companies have recently recalled products.
Since November 2023, the FDA has reported on an uptick in quality problems related to China-made plastic syringes. After a few U.S. companies switched manufacturers, some plastic syringes were produced with different dimensions than what the FDA approved them for, resulting in multiple recalls and safety notices.
The medical products might break, leak or be incompatible with infusion pumps.
Chicago-based Sol-Millennium Medical, one of the world's largest needle and syringe manufacturers, recalled its low dead space syringes, luer slip tip syringes, and syringes with needle and syringe components packaged together in May. China-based Jiangsu Shenli Medical Production Co. and Northfield, Ill.-based Medline have issued similar recalls.
In early June, South Jordan, Utah-based Merit Medical Systems became the fourth company to announce a recall of plastic syringes, according to the FDA. All of the companies have attributed the recalls to the FDA's investigation, which the agency said is "more widespread than originally known."