Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1359-2026 — Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

U.S. FDA — Device Enforcement · United Kingdom · 2023-01-20 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1359-2026
Date of alert
2023-01-20
Country / jurisdiction
United Kingdom
Risk level
Class III
Risk type
recall
Brand
SUREPULSE MEDICAL LTD
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05060550650037
Reported risk: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.