FDA Medical Device Recalls (openFDA)
SUREPULSE MEDICAL LTD: Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Recall number
- Z-1356-2026
- Recalling firm
- SUREPULSE MEDICAL LTD
- Product
- Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Status
- Open, Classified
- Initiated
- 2023-01-20
- Posted
- 2026-02-12
- Terminated
- not on file
- Reason
- Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- DI Number: 05060550650006/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
- 510(k) numbers
- ["K201887"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3018685978
- Firm city
- Nottingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28