Surepulse Medical Ltd Recalls VS Cap Extra Large Over Labeling Error
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Surepulse Medical Ltd is recalling specific lots of the Surepulse VS Cap Extra Large, used with newborn heart rate monitors, because the labeling features an incorrect sizing guide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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.
Original source: FDA Official Notice ↗
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