Recall events
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Event 98180
Event summary
Timeline bucket January 06, 2026
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording VANTIVE US HEALTHCARE LLC
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
8 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 8
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1224-2026
Recall number Z-1224-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 87,436 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1224-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35049]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 00085412954073, All lots including and manufactured after 24G0072
Distribution pattern US Nationwide distribution.
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[1172]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1225-2026
Recall number Z-1225-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 264,040 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1225-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11712]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 00085412917696, All lots including and manufactured after 24F0085
Distribution pattern US Nationwide distribution.
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[1280]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1226-2026
Recall number Z-1226-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 2,724 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1226-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35039]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
Distribution pattern US Nationwide distribution.
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[1103]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1227-2026
Recall number Z-1227-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 230,596 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1227-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35042]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Distribution pattern US Nationwide distribution.
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[1339]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1228-2026
Recall number Z-1228-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 137,576 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1228-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[35038]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA
Distribution pattern US Nationwide distribution.
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[1163]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1229-2026
Recall number Z-1229-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 93,576 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1229-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41122]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414069254, All lots including and manufactured after 24G0034CA
Distribution pattern US Nationwide distribution.
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[1180]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1230-2026
Recall number Z-1230-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 115,112 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1230-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52863]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
Distribution pattern US Nationwide distribution.
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[1379]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1231-2026
Recall number Z-1231-2026
Initiated January 06, 2026
Classification Class II
Status Ongoing
Quantity 13,760 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1231-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23414]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information UDI/DI 07332414111038, All lots including and manufactured after 24J0106
Distribution pattern US Nationwide distribution.
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[1327]
FDA event record
· Exact recall-number query on openFDA
