Device recall: Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Class III FDA enforcement event 98292. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
SUREPULSE MEDICAL LTD started this device recall on 20 Jan 2023. The firm address in the FDA record is in Nottingham. FDA put the recall in Class III. FDA event 98292 has 5 product records. The first FDA enforcement report date is 18 Feb 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
Recalling firm
SUREPULSE MEDICAL LTD, Nottingham, N/A, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1356-2026 | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor | N/A | Class III | Ongoing | 18 Feb 2026 |
| Z-1357-2026 | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor | N/A | Class III | Ongoing | 18 Feb 2026 |
| Z-1358-2026 | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor | N/A | Class III | Ongoing | 18 Feb 2026 |
| Z-1359-2026 | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor | N/A | Class III | Ongoing | 18 Feb 2026 |
| Z-1360-2026 | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor | N/A | Class III | Ongoing | 18 Feb 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class III
- 2%
- Product records in this event
- 5
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1356-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98292. https://recallregister.com/fda/iii/98292/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
- What quantity of product is in FDA event 98292?
- The event has 5 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 2% of the 917 device events that started in 2023 are in Class III.