Class III U.S. Food and Drug Administration

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart recall: Retroactively reported; Labeling contains incorrect sizing guide for Cap

Recall published 8 months ago

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1359-2026
Published
February 18, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Surepulse Medical Ltd
Product type
Medical devices
Units affected
N/A
Distribution
Nationwide
Made in
United Kingdom
Lot / code info
DI Number: 05060550650037/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
UPC codes
05060550650037

Products covered by this recall

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05060550650037

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 13816
  • 00001 13817
  • 00001 13818
  • 00001 13819
  • 00001 13820
  • 00001 13821
  • 00001

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Surepulse Medical Ltd — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: SUREPULSE MEDICAL LTD — Medicity D6 Thane Road, Nottingham

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Surepulse Medical Ltd medical devices recalled?

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05060550650037; lot code 13816, 00001 13817, 00001 13818. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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