Surepulse recalls a small cap component for newborn heart rate monitors due to incorrect sizing guide in labeling. This may lead to improper fit. Affected units include specific model numbers and production lots.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Surepulse is recalling a small cap component for newborn heart rate monitors because the labeling has an incorrect sizing guide. This could lead to improper fit when used with the monitor, potentially affecting accurate heart rate readings for newborns.
The cap component 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 heart rate readings for newborns, but does not pose an immediate physical danger.
New parents using Surepulse VS Newborn Heart Rate Monitors with the specific cap component (SP-160-A1) are most at risk. The recall affects a limited number of units with particular production lots.
Check if your newborn heart rate monitor includes the Surepulse VS Cap Small with model reference SP-160-A1. Affected units have specific production lots listed in the recall notice.
Verify if your newborn heart rate monitor uses the Surepulse VS Cap Small with model reference SP-160-A1.
The recall is for an incorrect sizing guide in labeling, which could lead to inaccurate heart rate readings but does not pose an immediate physical danger.
Check for the model reference SP-160-A1 on the cap and look for specific production lots listed in the recall notice.
No, the recall does not require stopping use; it only addresses labeling information for proper fit.
We’ve drafted a message you can send Surepulse to request your refund or repair — edit it as you like.
Subject: Recall Z-1357-2026 — Surepulse Surepulse Hello, I own a Surepulse that is covered by recall Z-1357-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
