FDA recall, , Low risk
Surepulse VS Newborn Heart Rate Monitor Caps
Surepulse VS Cap has incorrect sizing guide on its label.
Summary by Recall Canary from the FDA notice
What happened
SUREPULSE MEDICAL LTD, of Nottingham, United Kingdom, began a recall on January 20, 2023, for the Surepulse VS Cap, a component of the VS Newborn Heart Rate Monitor. The recall, added to the FDA's Enforcement Report on February 12, 2026, affects the Extra Small, Small, Medium, Large, and Extra Large caps because the labeling contains an incorrect sizing guide. The caps were distributed in Connecticut and Texas, as well as the United Kingdom, the Netherlands, and the United Arab Emirates.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
- UDI-DI
- 05060550650037
- Lot code
- 13816
- 00001
- 13817
- 13818
- 13819
- 13820
- 13821
- 13822
- 13823
- 13824
- 13825
- 13826
- 13827
- 13828
- 13829
- 13830
- 13831
- 13832
- 13833
- 13834
- 13835
- 13836
- 13837
- 13838
- 13839
- 13840
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- UDI-DI
- 05060550650020
- Lot code
- 13816
- 00001
- 13817
- 13818
- 13819
- 13820
- 13821
- 13822
- 13823
- 13824
- 13825
- 13826
- 13827
- 13828
- 13829
- 13830
- 13831
- 13832
- 13833
- 13834
- 13835
- 13836
- 13837
- 13838
- 13839
- 13840
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- UDI-DI
- 05060550650013
- Lot code
- 13816
- 00001
- 13817
- 13818
- 13819
- 13820
- 13821
- 13822
- 13823
- 13824
- 13825
- 13826
- 13827
- 13828
- 13829
- 13830
- 13831
- 13832
- 13833
- 13834
- 13835
- 13836
- 13837
- 13838
- 13839
- 13840
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
- UDI-DI
- 05060550650044
- Lot code
- 13816
- 00001
- 13817
- 13818
- 13819
- 13820
- 13821
- 13822
- 13823
- 13824
- 13825
- 13826
- 13827
- 13828
- 13829
- 13830
- 13831
- 13832
- 13833
- 13834
- 13835
- 13836
- 13837
- 13838
- 13839
- 13840
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- UDI-DI
- 05060550650006
- Lot code
- 13816
- 00001
- 13817
- 13818
- 13819
- 13820
- 13821
- 13822
- 13823
- 13824
- 13825
- 13826
- 13827
- 13828
- 13829
- 13830
- 13831
- 13832
- 13833
- 13834
- 13835
- 13836
- 13837
- 13838
- 13839
- 13840
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Connecticut, Texas and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
- Company
- SUREPULSE MEDICAL LTDNottingham, United Kingdom
- Hazard
- Labeling error
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98292
- Recall numbers
- Z-1356-2026 to Z-1360-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
