VS Cap Large SP-162-A-1Recalls & reported problems
Surepulse Medical Limited · VS Cap Large · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K201887); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jan 20, 2023Open, Classified
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Z-1359-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201887. One submission often covers many models, so check the product and lot details in each record.
- Z-1358-2026 · Jan 20, 2023 · Open, ClassifiedSurepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Z-1357-2026 · Jan 20, 2023 · Open, ClassifiedSurepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- Z-1356-2026 · Jan 20, 2023 · Open, ClassifiedSurepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Z-1360-2026 · Jan 20, 2023 · Open, ClassifiedSurepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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