SurePulse Medical Ltd Recalls Surepulse VS Cap Medium Over Incorrect Sizing Label

What Happened

SurePulse Medical Ltd has issued a voluntary recall for the Surepulse VS Cap Medium. The recall was initiated because the product labeling contains an incorrect sizing guide for the cap, which is a critical component of the VS Newborn Heart Rate Monitor. This labeling error was retroactively reported and has been classified by the FDA as a Class III recall.

Which Products Are Affected

The recall affects the following medical device component:

• Product Name: Surepulse VS Cap Medium (component of VS Newborn Heart Rate Monitor)
• Model/REF Number: SP-161-A1
• DI Number: 05060550650020
• Lot Numbers: 13816/00001 through 13840/00001
• Recall Number: Z-1358-2026

Distribution of the affected products was worldwide, including United States nationwide distribution with specific records for Connecticut (CT) and Texas (TX). International distribution included the United Kingdom, Netherlands, and the United Arab Emirates.

What You Should Do

Healthcare providers and facilities utilizing the VS Newborn Heart Rate Monitor should check their inventory for the affected lot numbers and REF: SP-161-A1. Users should be aware that the sizing guide on the current labeling is incorrect. For further information or instructions regarding the labeling correction, contact SurePulse Medical Ltd at their headquarters in Nottingham, United Kingdom.

Why This Matters

This recall is classified as Class III, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, accurate labeling is necessary to ensure the proper fit of monitoring equipment for newborns.

Source

Information provided by the FDA under Recall Number Z-1358-2026.