Medline and Jiangsu Shenli Medical Production Co. have initiated recalls of plastic syringes amid reports of them breaking and leaking, the FDA confirmed in late May.
The two companies have recalled 82 syringe lots, according to the FDA.
The news comes about five months after the agency told healthcare facilities to avoid using plastic syringes made in China because of these quality issues. The problem might be tied to manufacturers recently changing product dimensions, making the plastic syringes incompatible with infusion pumps, the FDA has previously said.
On March 18, the agency said the syringe issue is "more widespread than originally known." Since then, three China-based medical supply manufacturers have received import alerts, and the FDA recommends healthcare immediately transition away from China-based syringe manufacturers.
"The FDA will continue our extensive efforts to evaluate problems with plastic syringes manufactured in China," the agency said, "including facility inspections, examining products at the border and detaining them as appropriate, laboratory testing of syringes, and working with manufacturers, when applicable, to ensure adequate corrective actions are taken.