Surepulse Medical Ltd Recalls VS Cap Extra Large Over Labeling Error

What Happened

Surepulse Medical Ltd has initiated a voluntary recall of the Surepulse VS Cap Extra Large. The recall was prompted by the discovery that the product labeling contains an incorrect sizing guide for the cap, which is a component used with the VS Newborn Heart Rate Monitor.

Which Products Are Affected

The recall involves the Surepulse VS Cap Extra Large (REF: SP-163-A1). The affected products are identified by DI Number 05060550650044 and the following lot numbers:

• 13816/00001 through 13840/00001

Distribution of these units was worldwide, including nationwide in the United States with specific distribution noted in Connecticut and Texas. International distribution included the United Kingdom, Netherlands, and the United Arab Emirates.

What You Should Do

Healthcare providers and facilities using the VS Newborn Heart Rate Monitor should check their inventory for the affected lot numbers. Users should be aware that the sizing guide on the current labeling is incorrect. For further instructions regarding replacement or corrected labeling, contact Surepulse Medical Ltd, located at Medicity D6 Thane Road, Nottingham, United Kingdom.

Why This Matters

Correct sizing is important for the proper application of medical components used on newborns. An incorrect sizing guide could lead to improper fitment of the heart rate monitor component. This is a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Source

Information provided by the FDA. Recall Number: Z-1360-2026.