Z-1359-2026Class III

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

Name: Z-1359-2026 Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Creator: Surepulse Medical Ltd
Published: 2023-01-20
License: https://open.fda.gov/license/

Surepulse Medical Limited / initiated 2023-01-20 / Open, Classified / root cause: labeling and UDI

FDA source

SUREPULSE MEDICAL LTD began a recall of Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor on 2023-01-20. FDA classified it as Class III and gives the reason as "Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1359-2026
Classification: Class III
Status: Open, Classified
Initiated: 2023-01-20
Posted: 2026-02-12
Recalling firm: Surepulse Medical Limited
Product: Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Product code: DQA Oximeter
Reason for recall: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1359-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1356-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12
Z-1357-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12
Z-1358-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12
Z-1359-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12
Z-1360-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-12

Product code DQA

K201887Class IIVS Newborn Heart Rate MonitorSurepulse Medical Limited / cleared 2021-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)