SurePulse Medical
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SurePulse Medical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-18FDA-DeviceClass IIICheck Surepulse newborn heart monitor cap sizing
Surepulse Medical has recalled the VS Cap Extra Large component used in their VS Newborn Heart Rate Monitor because the labeling includes an incorrect sizing guide. This could lead to improper fit of the cap on the monitor. No injuries have been reported.
- 2026-02-18FDA-DeviceClass IIICheck Surepulse VS Cap sizing label
The labeling for the Surepulse VS Cap Large, a component of the VS Newborn Heart Rate Monitor, contains an incorrect sizing guide. This labeling error could lead to improper fit of the cap during use. No injuries have been reported.
- 2026-02-18FDA-DeviceClass IIICheck Surepulse VS Cap Medium sizing label
Surepulse Medical has recalled the VS Cap Medium (part number SP-161-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling contains an incorrect sizing guide. This labeling error could affect proper fit of the cap during use.
- 2026-02-18FDA-DeviceClass IIICheck Surepulse VS Cap Small sizing guide
The labeling for the Surepulse VS Cap Small component of the VS Newborn Heart Rate Monitor contains an incorrect sizing guide. This affects specific lot numbers distributed in the US and several other countries. No injuries have been reported.
- 2026-02-18FDA-DeviceClass IIICheck Surepulse newborn heart monitor cap labeling
Surepulse Medical has recalled the VS Cap Extra Small (REF: SP-159-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling includes an incorrect sizing guide. This labeling error could lead to improper cap selection for the device.
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