SUREPULSE MEDICAL LTD: Medical Device Recall in 2026 - (Recall #: Z-1360-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

Product Classification:

Class III

Date Initiated: January 20, 2023

Date Posted: February 18, 2026

Recall Number: Z-1360-2026

Event ID: 98292

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

Code Information:

DI Number: 05060550650044/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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated