The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1999-2026·Announced 2026-05-06

Abbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results

Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of medical devices that pose risk of harm to patients (potential for unnecessary harmful clinical interventions and delayed diagnosis). The source states no illnesses or injuries have been reported, making the severity a High (3) rather than Severe (4), per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Abbott Point Of Care Inc. is recalling specific lots of i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25), and i-STAT G3+ (list number 03P78-26) blood gas cartridges due to a manufacturing issue. Approximately 7.6% of cartridges from affected lots in the U.S. marketplace may report higher than expected pCO2 and lower than expected pH results.

The inaccurate results can make blood gas readings appear as though a patient is in severe respiratory acidosis when they are not. If clinicians rely on these false values, they may implement unnecessary or potentially harmful interventions, including unnecessary ventilator adjustments, unnecessary medications, potential harm from overcorrection, or delays in identifying the patient's true clinical condition.

The recalled cartridges were distributed worldwide, including throughout the United States and to Canada, Austria, Bangladesh, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, Mauritius, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. A total of 369,650 units were distributed (150,875 in the U.S., 218,775 outside the U.S.). Affected lot numbers are N25206, N25207, N25209, N25213, N25218, N25219, and N25233.

The recalled product

Product
i-STAT EG7+ cartridge; List Number: 03P76-25;
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Blood Gas Analyzer Cartridge
Hazard

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 (9)

  • List Number: 03P76-25
  • UDI-DI: 00054749000043
  • Lot numbers: N25206
  • N25207
  • N25209
  • N25213
  • N25218
  • N25219
  • N25233

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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