Surepulse Medical Ltd Recalls VS Cap Large Due to Incorrect Labeling Sizing Guide
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Surepulse Medical Ltd has initiated a voluntary recall of the Surepulse VS Cap Large, a component of the VS Newborn Heart Rate Monitor, due to an incorrect sizing guide on the product labeling.
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, MedicalDevices.
What Happened
Surepulse Medical Ltd has voluntarily initiated a recall for the Surepulse VS Cap Large. The recall was triggered after it was determined that the product labeling contains an incorrect sizing guide for the cap, which serves as a component of the VS Newborn Heart Rate Monitor. This issue was retroactively reported and has been classified as a Class III recall by the FDA.
Which Products Are Affected
The recall affects the following medical device component:
- Product Name: Surepulse VS Cap Large (component of VS Newborn Heart Rate Monitor)
- Model/REF Number: SP-162-A1
- DI Number: 05060550650037
- Lot Numbers: 13816/00001 through 13840/00001
- Recall Number: Z-1359-2026
Distribution of the affected products occurred nationwide in the United States, specifically within the states of Connecticut (CT) and Texas (TX), as well as internationally in 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 (13816/00001 through 13840/00001) of the VS Cap Large. Users should be aware that the sizing guide provided on the labeling for these specific lots is incorrect. For further information regarding the return or correction of the labeling, contact Surepulse Medical Ltd at their Nottingham, United Kingdom headquarters.
Why This Matters
This recall is significant as it addresses a labeling error that could lead to the selection of an improperly sized cap for newborn heart rate monitoring. Ensuring accurate sizing information is essential for the proper function and fit of neonatal medical equipment.
Source
Information provided by the U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
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