Surepulse Medical Ltd Recalls VS Cap Extra Small Due to Incorrect Sizing Labeling
Surepulse Medical Ltd has issued a voluntary recall for its VS Cap Extra Small, a component of the VS Newborn Heart Rate Monitor, due to an incorrect sizing guide on the product labeling.
What Happened
Surepulse Medical Ltd has retroactively reported a voluntary, firm-initiated recall of the Surepulse VS Cap Extra Small. The recall was triggered because the product labeling contains an incorrect sizing guide for the cap, which serves as a component of the VS Newborn Heart Rate Monitor. The FDA has classified this as a Class III recall.
Which Products Are Affected
The recall affects the following medical device component:
- Product Name: Surepulse VS Cap Extra Small (component of VS Newborn Heart Rate Monitor)
- Reference Number: SP-159-A1
- DI Number: 05060550650006
- Lot Numbers: 13816/00001 through 13840/00001 (inclusive)
The product was distributed worldwide, including nationwide in the United States with specific distribution noted in 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 of the Extra Small caps. Users should be aware that the sizing guide on the current labeling is incorrect. For further instructions regarding labeling updates or product returns, contact Surepulse Medical Ltd at their Nottingham, United Kingdom headquarters.
Why This Matters
While this is a Class III recall—meaning the labeling error is not likely to cause adverse health consequences—accurate sizing information is important for the proper application of heart rate monitoring equipment on newborns.
Source
Information provided by the FDA under recall number Z-1356-2026.
Source: FDA Official Notice