Insulin Overdose Risk Results in Recall of 1.4M Smiths Medical Mislabeled Syringes

About 1.4 million Smiths Medical syringes are being recalled because the dosage markings may have been incorrectly printed on the barrels, which could lead to an overdose or underdose of insulin.

The FDA announced the Smiths Medical Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe recall on June 25, warning the graduated markings on the syringe barrels may be skewed approximately 20 degrees upward, which could result in incorrect dosage delivery and increase the risk of patient harm or death.

According to the syringe recall notice, the manufacturer has received at least nine complaints of patients accidentally receiving too much or too little insulin due to the incorrect dosing markers on the syringe barrels. However, no serious injuries or deaths have been reported to date.

The recall involves approximately 1,431,000 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes intended for single-use to draw and inject insulin into a patient.

An insulin overdose can result in hypoglycemia (low blood sugar levels) or even death. Symptoms of an insulin overdose can include anxiety, confusion, extreme hunger, irritability, sweating, and tremors or trembling hands, increased pulse rate, irregular heartbeat, headaches or nausea.

Smiths Medical sent an Urgent Medical Device Recall notice to all known distributors and healthcare facilities on May 17, instructing customers to stop using the recalled syringes and to immediately quarantine any remaining inventory.

The recall includes Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes 28Gx1/2” 1CC with model number 4428-1. They are marked with lot numbers 4046543 or 4062235. The recall also affects Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes 29Gx1/2” 1CC with model number 4429-1 and lot numbers 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 406224.

The recalled syringes were manufactured by Smiths Medical Inc., of Minneapolis, Minnesota. They were distributed to healthcare facilities and distributors nationwide from October 31, 2020 to January 10, 2021.

Since the initial recall notice, the FDA has given the recall a Class I designation, the most serious recall category. This indicates the FDA believes use of the product may result in serious patient injury or death.

Customers with recalled Jelco syringes should contact Smiths Medical at fieldactions@smith-medical.com to receive a prepaid shipping label to return all recalled products. Healthcare professionals and patients are encouraged to report any adverse events arising from the use of the products to MedWatch, the FDA’s adverse event reporting program.