SurePulse Medical Ltd Recalls Surepulse VS Cap Small Due to Labeling Error

What Happened

SurePulse Medical Ltd has initiated a voluntary recall of the Surepulse VS Cap Small. 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 following medical device component:

• Product Name: Surepulse VS Cap Small (component of VS Newborn Heart Rate Monitor)
• Reference Number: SP-160-A1
• DI Number: 05060550650013
• Lot Numbers: 13816/00001 through 13840/00001

Distribution was worldwide, including US nationwide distribution with specific records for Connecticut (CT) and Texas (TX), as well as the United Kingdom, Netherlands, and 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. Because the labeling contains an incorrect sizing guide, users should ensure they are using the appropriate size for the patient regardless of the printed guide. For further instructions regarding the labeling correction or potential returns, contact SurePulse Medical Ltd at their headquarters in Nottingham, United Kingdom.

Why This Matters

Accurate labeling and sizing guides are necessary for medical components used on newborns to ensure the device fits correctly and functions as intended for heart rate monitoring.

Source

Information provided by the FDA under recall number Z-1357-2026.