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VS Cap Small SP-160-A-1Recalls & reported problems

Surepulse Medical Limited · VS Cap Small · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K201887); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 20, 2023Open, Classified

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

    Z-1357-2026 · Root cause: Labeling Change Control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201887. One submission often covers many models, so check the product and lot details in each record.

  • Z-1358-2026 · Jan 20, 2023 · Open, Classified
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
  • Z-1356-2026 · Jan 20, 2023 · Open, Classified
    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
  • Z-1360-2026 · Jan 20, 2023 · Open, Classified
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
  • Z-1359-2026 · Jan 20, 2023 · Open, Classified
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Other Oximeter devices

All Oximeter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.