Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Recall Insight

This FDA Devices action (record #Z-1358-2026) was formally reported on February 18, 2026, with the manufacturer initiating the action on January 20, 2023. It is classified under Low severity (Class III), with a current status of Ongoing. SUREPULSE MEDICAL LTD is listed as the recalling firm, operating out of Nottingham, N/A. Federal records indicate N/A units are affected.

The documented reason for this recall is: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.