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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97296

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 04, 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

3 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 3

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

Z-2332-2025
Recall number
Z-2332-2025
Initiated
August 04, 2025
Classification
Class I
Status
Ongoing
Quantity
43,922 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Code information

UDI/DI 05413765851797, All Serial Numbers

Distribution pattern

US distribution including Puerto Rico and OUS (International) Canada

device · product 2 of 3

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Z-2333-2025
Recall number
Z-2333-2025
Initiated
August 04, 2025
Classification
Class I
Status
Ongoing
Quantity
10,101 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Code information

UDI/DI 05413765852428, All Serial Numbers

Distribution pattern

US distribution including Puerto Rico and OUS (International) Canada

device · product 3 of 3

Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

Z-2334-2025
Recall number
Z-2334-2025
Initiated
August 04, 2025
Classification
Class I
Status
Ongoing
Quantity
22703 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomalies

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Code information

UDI/DI N/A, All Serial Numbers

Distribution pattern

US distribution including Puerto Rico and OUS (International) Canada