FDA Issues Update on Guangdong Haiou Medical’s Syringe Recall

The FDA has urged healthcare providers to stop using two needle-containing syringes recalled in June by China-based Guangdong Haiou Medical Apparatus.

The affected needles and needle holders may detach from the syringe after injection, leaving the needle in the patient’s arm. There is also a risk that the affected needles may not retract into the syringe, resulting in an increased risk of needle stick injury to the end user, the agency said.

The recalled devices include the company’s 1mL syringe with a 25 gauge 1-inch needle and its 1mL syringe with 23 gauge 1-inch needle configurations, including combinations of syringes and needles with needle safety devices.

“Be aware that these syringes and needle configurations may be available as individual units or may be included as part of a kit,” the agency said.

The company had declined to issue a recall in early 2021, which led the FDA to place it on an import alert in April 2021 to prevent the products from entering the U.S.