Recall events
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Event 98292
Event summary
Timeline bucket January 20, 2023
Product types Device
Classifications Class III
Statuses Ongoing
Recalling firm wording SUREPULSE MEDICAL LTD
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
5 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Z-1356-2026
Recall number Z-1356-2026
Initiated January 20, 2023
Classification Class III
Status Ongoing
Quantity N/A
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling contains incorrect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1356-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41129]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information 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
Distribution pattern 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.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1114]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Z-1357-2026
Recall number Z-1357-2026
Initiated January 20, 2023
Classification Class III
Status Ongoing
Quantity N/A
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling contains incorrect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1357-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[47043]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information DI Number: 05060550650013/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
Distribution pattern 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.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1305]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Z-1358-2026
Recall number Z-1358-2026
Initiated January 20, 2023
Classification Class III
Status Ongoing
Quantity N/A
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling contains incorrect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1358-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[47045]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information 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
Distribution pattern 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.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1239]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Z-1359-2026
Recall number Z-1359-2026
Initiated January 20, 2023
Classification Class III
Status Ongoing
Quantity N/A
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling contains incorrect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1359-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17655]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information 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
Distribution pattern 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.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1071]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Z-1360-2026
Recall number Z-1360-2026
Initiated January 20, 2023
Classification Class III
Status Ongoing
Quantity N/A
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
Labeling contains incorrect
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1360-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23406]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Code information DI Number: 05060550650044/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
Distribution pattern 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.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[1271]
FDA event record
· Exact recall-number query on openFDA
