Surepulse recalls VS Cap Extra Small (SP-159-A1) for incorrect sizing guide on newborn heart rate monitor. This may lead to improper fit.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Surepulse is recalling the VS Cap Extra Small (model SP-159-A1) because its labeling has an incorrect sizing guide. This could cause improper fit when used with newborn heart rate monitors.
The cap has an incorrect sizing guide in its labeling, which could lead to improper fit when attached to the heart rate monitor. This might cause inaccurate readings but does not pose a direct physical risk.
Newborn caregivers who own the Surepulse VS Newborn Heart Rate Monitor with the specific cap model SP-159-A1 are affected. Newborns are at the highest risk due to the device's use.
Check if your Surepulse VS Newborn Heart Rate Monitor includes the VS Cap Extra Small with model number SP-159-A1. The cap was sold with specific production lots from 13816 to 13840.
Verify your cap's model number is SP-159-A1 to confirm it's part of this recall.
The recall states the labeling has an incorrect sizing guide, which could lead to improper fit but does not pose a direct physical risk. The device itself is safe for use.
Look for the model number SP-159-A1 on the cap, which was sold with production lots from 13816 to 13840.
No, the recall does not require stopping use; the issue is with the cap's labeling, not the device's safety.
We’ve drafted a message you can send Surepulse to request your refund or repair — edit it as you like.
Subject: Recall Z-1356-2026 — Surepulse Surepulse Hello, I own a Surepulse that is covered by recall Z-1356-2026 from Surepulse. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.