CLASS III ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Surepulse VS Cap Medium recalled by Surepulse Medical
Surepulse Medical is recalling Surepulse VS Cap Medium, distributed nationwide in the US. The recall was initiated on 20 Jan 2023 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1358-2026
- FDA event ID
- 98292
- Recalling firm
- Surepulse Medical, Nottingham, N/A
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 20 Jan 2023
- FDA classified
- 12 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 20 Jan 2023 | Recall initiated by company | |
| 12 Feb 2026 | Classified by FDA | +1119 days |
| 18 Feb 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Product as listed by the FDA
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Where it was distributed
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.
Questions about this recall
Is Surepulse VS Cap Medium recalled?
Yes. Surepulse Medical recalled Surepulse VS Cap Medium on 20 Jan 2023. The recall is Class III and its status is Ongoing. Recall number Z-1358-2026.
Why was it recalled?
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Which lots are affected?
DI Number: 05060550650020/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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Surepulse Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Surepulse VS Cap Extra Large recalled by Surepulse Medical | Surepulse Medical | Other | Nationwide |
| Device | CLASS III | Surepulse VS Cap Extra Small recalled by Surepulse Medical | Surepulse Medical | Other | Nationwide |
| Device | CLASS III | Surepulse VS Cap Small recalled by Surepulse Medical | Surepulse Medical | Other | Nationwide |
| Device | CLASS III | Surepulse VS Cap Large recalled by Surepulse Medical | Surepulse Medical | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |