SurePulse Medical Ltd Recalls Surepulse VS Cap Small Due to Labeling Error
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SurePulse Medical Ltd has issued a voluntary recall for the Surepulse VS Cap Small, a component of newborn heart rate monitors, because of an incorrect sizing guide on the product label.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. 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 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.
Original source: FDA Official Notice ↗
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