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Baxter10-K: Quality issue

Class I recalls on Novum LVP infusion pumps led to a distribution halt and $105M in charges in 2025.

What happened

Multiple voluntary corrections for the Novum LVP, classified as Class I recalls by the FDA due to infusion risks, forced a distribution and installation stop in the U.S. and Canada.

Source

SEC EDGARFeb 12, 2026

Annual report (Form 10-K)

Baxter 10-K for FY2025

Filing excerpt

Beginning in July 2025, we initiated voluntary corrections for the Novum LVP due to the potential for over- and under-infusion related to set misloading, as well as certain software anomalies. The U.S. Food and Drug Administration (FDA) classified these voluntary corrections as Class I recalls.

sec.gov/Archives/edgar/data/10456/000162828026007733/bax-20251231.htmRead the full source

Other signals in this filing (11)

Extracted by Autobound

From the Signal API record
Signal
10-K: Quality issue

What this signalsFilings often name leadership changes, deals and spending plans.

Period
FY2025
Fiscal year end
12/31
Filed
Feb 12, 2026

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The full record

From the Signal API record

Numbers

Dollar figure
$105M (Aggregate charges in 2025 for sales reductions, returns, remediation, and write-downs for Novum LVP corrections.)

Details

CIK
10456
Accession number
0001628280-26-007733
Timeframe
Current year
Filing year
2026
Why it matters
Quality management needed
Signal category
Operations

Topics and mentions

Regions named

  • United States
  • Canada

Extraction

Confidence
High
Relevance
100%
Sentiment
Negative
Detected
Feb 17, 2026
signal_type
sec-10k
signal_subtype
qualityIssue

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This page shows a preview. The full sec-10k record in the Signal API and MCP can also have these 8 fields. Some fields are empty for some signals.

Company

  • linkedin_urlValue in the API
  • industriesValue in the API
  • employee_count_lowValue in the API
  • employee_count_highValue in the API
  • revenueValue in the API
  • descriptionValue in the API

Signal

  • signal_nameValue in the API
  • associationValue in the API
Show the full JSONThe record on this page and the API request

GET /v1/signals/2a4bb8ac-d8d5-43b4-88a1-74fbca1f714b returns this record as JSON. POST /v1/companies/enrich returns every signal for baxter.com.

{
  "signal_id": "2a4bb8ac-d8d5-43b4-88a1-74fbca1f714b",
  "signal_type": "sec-10k",
  "signal_subtype": "qualityIssue",
  "detected_at": "2026-02-17T06:36:40.174+00:00",
  "company": {
    "name": "Baxter",
    "domain": "baxter.com"
  },
  "data": {
    "detail": "Multiple voluntary corrections for the Novum LVP, classified as Class I recalls by the FDA due to infusion risks, forced a distribution and installation stop in the U.S. and Canada. This has resulted in significant financial charges for remediation, returns, and write-downs, creating an urgent need for quality management, product testing, and remediation solutions.",
    "metrics": {
      "timeframe": "current_year",
      "dollar_context": "Aggregate charges in 2025 for sales reductions, returns, remediation, and write-downs for Novum LVP corrections.",
      "dollar_millions": 105
    },
    "summary": "Class I recalls on Novum LVP infusion pumps led to a distribution halt and $105M in charges in 2025.",
    "excerpts": "Beginning in July 2025, we initiated voluntary corrections for the Novum LVP due to the potential for over- and under-infusion related to set misloading, as well as certain software anomalies. The U.S. Food and Drug Administration (FDA) classified these voluntary corrections as Class I recalls.",
    "relevance": 1,
    "sentiment": "negative",
    "confidence": "high",
    "source_url": "https://www.sec.gov/Archives/edgar/data/10456/000162828026007733/bax-20251231.htm",
    "filing_date": "2026-02-12",
    "filing_year": 2026,
    "fiscal_year_end": "12/31",
    "sales_relevance": "Quality management needed",
    "signal_category": "operations",
    "regions_mentioned": [
      "United States",
      "Canada"
    ]
  }
}

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