Class III U.S. Food and Drug Administration

Surepulse VS Cap Small REF: SP-160-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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1357-2026
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: 05060550650013/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
05060550650013

Products covered by this recall

Surepulse VS Cap Small REF: SP-160-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.

  • 05060550650013

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 05060550650013; 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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