Surepulse recalls VS Cap Medium (REF: SP-161-A1) for newborn heart rate monitors due to incorrect sizing guide in labeling. Affected units sold with specific lot numbers.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Surepulse is recalling the VS Cap Medium component (REF: SP-161-A1) for newborn heart rate monitors because the labeling has an incorrect sizing guide. This could lead to improper fitting, but the recall does not mention specific injury risks or immediate danger.
The labeling contains an incorrect sizing guide for the cap, which could result in improper fitting. This might affect the monitor's accuracy but does not indicate a risk of injury or serious harm under normal use.
Newborn heart rate monitor users who own the VS Cap Medium component (REF: SP-161-A1) with the listed lot numbers. Parents and caregivers are most at risk if the cap fits incorrectly.
Check if your newborn heart rate monitor includes the VS Cap Medium component (REF: SP-161-A1) with lot numbers 13816 through 13840. The cap is a small part used in the monitor.
Verify your VS Cap Medium (REF: SP-161-A1) has the listed lot numbers (13816-13840) to confirm it is affected.
The recall states the labeling has an incorrect sizing guide, which could affect fitting but does not indicate a risk of injury or serious harm under normal use.
Check if your VS Cap Medium (REF: SP-161-A1) has lot numbers 13816 through 13840 as listed in the recall.
The recall does not specify a remedy, so you can continue using the monitor if it fits properly, but check the labeling for correct sizing.
We’ve drafted a message you can send Surepulse to request your refund or repair — edit it as you like.
Subject: Recall Z-1358-2026 — Surepulse Surepulse Hello, I own a Surepulse that is covered by recall Z-1358-2026 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.
