SurePulse Medical Ltd Recalls Surepulse VS Cap Medium Over Incorrect Sizing Label
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
SurePulse Medical Ltd has initiated a voluntary recall of the Surepulse VS Cap Medium, a newborn heart rate monitor component, 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 issued a voluntary recall for the Surepulse VS Cap Medium. The recall was initiated because the product labeling contains an incorrect sizing guide for the cap, which is a critical component of the VS Newborn Heart Rate Monitor. This labeling error was retroactively reported and has been classified by the FDA as a Class III recall.
Which Products Are Affected
The recall affects the following medical device component:
- Product Name: Surepulse VS Cap Medium (component of VS Newborn Heart Rate Monitor)
- Model/REF Number: SP-161-A1
- DI Number: 05060550650020
- Lot Numbers: 13816/00001 through 13840/00001
- Recall Number: Z-1358-2026
Distribution of the affected products was worldwide, including United States nationwide distribution with specific records for Connecticut (CT) and Texas (TX). International distribution included the United Kingdom, Netherlands, and the 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 and REF: SP-161-A1. Users should be aware that the sizing guide on the current labeling is incorrect. For further information or instructions regarding the labeling correction, contact SurePulse Medical Ltd at their headquarters in Nottingham, United Kingdom.
Why This Matters
This recall is classified as Class III, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, accurate labeling is necessary to ensure the proper fit of monitoring equipment for newborns.
Source
Information provided by the FDA under Recall Number Z-1358-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.