Recall events
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Event 97072
Event summary
Timeline bucket June 20, 2025
Product types Device
Classifications Class I
Statuses Ongoing
Recalling firm wording Baxter Healthcare Corporation
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
2 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 2
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Z-2095-2025
Recall number Z-2095-2025
Initiated June 20, 2025
Classification Class I
Status Ongoing
Quantity 14 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect version of software
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2095-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23324]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Certain Spectrum infusion pumps may have an incorrect version of software.
Code information UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523
Distribution pattern US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
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[2822]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 2
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Z-2096-2025
Recall number Z-2096-2025
Initiated June 20, 2025
Classification Class I
Status Ongoing
Quantity 28 units
App-derived interpretation
Device software or design
reason.device_software_design · v1.0.0
incorrect version of software
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Employee error
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2096-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57995]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Certain Spectrum infusion pumps may have an incorrect version of software.
Code information UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201
Distribution pattern US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
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[2631]
FDA event record
· Exact recall-number query on openFDA
