Surepulse VS Cap Large recallZ-1359-2026 · Surepulse Medical Ltd · initiated Jan 20, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Surepulse Medical Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA root cause category: Labeling Change Control
What the company is doing
On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.
Recall details
- Recall number
- Z-1359-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 20, 2023
- Posted by the FDA
- Feb 12, 2026
- Recalling firm
- Surepulse Medical Ltd
- Product code
- DQA
- FDA submissions
- K201887
- Distribution
- Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
Product description
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Code information (models, lots, serial numbers)
DI Number: 05060550650037/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VS Cap Large SP-162-A-1Surepulse Medical Limited · Oximeter1 recall0 reports
Other devices under the same FDA submission
4 devices cleared under K201887 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VS Cap Extra Small SP-159-A-1Surepulse Medical Limited · Oximeter1 recall0 reports
- VS Cap Small SP-160-A-1Surepulse Medical Limited · Oximeter1 recall0 reports
- VS Cap Medium SP-161-A-1Surepulse Medical Limited · Oximeter1 recall0 reports
- VS Cap Extra Large SP-163-A-1Surepulse Medical Limited · Oximeter1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98292).
- Z-1356-2026 · Open, ClassifiedSurepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Z-1357-2026 · Open, ClassifiedSurepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- Z-1358-2026 · Open, ClassifiedSurepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Z-1360-2026 · Open, ClassifiedSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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