The Recall Desk
HighFDA (Devices)·Z-2000-2026·Announced 2026-05-06

i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results

Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with potential for significant patient harm (unnecessary ventilator changes, medications, and delays in identifying true problems). Although no illnesses or injuries are explicitly reported in the source, the hazard is direct and the risk is substantial—this is a diagnostic device where incorrect results can lead to harmful clinical decisions.

Plain-English summary

Abbott Point Of Care Inc. is recalling approximately 30,775 units of i-STAT blood gas analyzer cartridges (i-STAT EG7+, i-STAT EG6+, and i-STAT G3+ models) distributed worldwide. Approximately 7.6% of cartridges from specific lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue.

When falsely high pCO2 results are combined with falsely low pH values, the blood gas readings may incorrectly suggest the patient is in severe respiratory acidosis. If clinicians believe these inaccurate values are accurate, they may initiate unnecessary or harmful interventions, including unnecessary ventilator adjustments, unnecessary medications, potential harm from overcorrection, or delays in identifying the patient's true clinical condition.

Patients and healthcare providers who have used affected cartridges should review test results in clinical context and contact Abbott or their healthcare provider if they have concerns about test accuracy or patient outcomes.

The recalled product

Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Diagnostic / Blood Gas Analyzer Cartridge
Hazard
  • inaccurate-diagnostic-results
  • respiratory-acidosis-misidentification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • List Number: 03P77-25
  • UDI-DI: 00054749000050
  • Lot number: N25223A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category