Recall events
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Event 97989
Event summary
Timeline bucket November 05, 2025
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Diasol, Inc
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
6 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 6
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0987-2026
Recall number Z-0987-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 186,000 containers
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0987-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46586]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1699]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 6
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0988-2026
Recall number Z-0988-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 7,200 gallons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0988-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17616]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None/Lot Code: PHV08081,PHV09042
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1831]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 6
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0989-2026
Recall number Z-0989-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 4400 gallons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0989-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5751]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None/Lot Code: PHV08112,PHV10082
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1543]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 6
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0990-2026
Recall number Z-0990-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 4,400 gallons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0990-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41056]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None/Lot Code: PHV07222,PHV09082
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1498]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 6
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0991-2026
Recall number Z-0991-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 74,400 gallons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0991-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41054]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1428]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 6
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Z-0992-2026
Recall number Z-0992-2026
Initiated November 05, 2025
Classification Class II
Status Ongoing
Quantity 2200 gallons
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Safety and efficacy of dialysis acid concentrate cannot be assured
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0992-2026
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17618]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Safety and efficacy of dialysis acid concentrate cannot be assured
Code information UDI: None/Lot Code: PHV08042
Distribution pattern US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
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[1329]
FDA event record
· Exact recall-number query on openFDA
