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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

i-STAT Cartridges Recalled for Potential False Blood Gas Results

Agency Publication Date: April 29, 2026
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Summary

Abbott Point Of Care Inc. is recalling approximately 440,700 i-STAT blood testing cartridges, including models EG7+, EG6+, and G3+, because a manufacturing issue may cause them to report incorrect patient results. Specifically, about 7.6% of these cartridges may report falsely high carbon dioxide levels and falsely low pH levels. These devices are used in clinical settings to measure critical blood gas levels, and inaccurate readings can lead to unnecessary or dangerous medical treatments, such as improper ventilator adjustments or overcorrection with medications.

Risk

A falsely high carbon dioxide and low pH reading makes a patient appear to be in severe respiratory acidosis. If a clinician relies on these inaccurate values, they may perform unnecessary ventilator changes or administer medications that could harm the patient or delay the identification of their actual medical condition.

What You Should Do

  1. Check your inventory for i-STAT EG7+ (List Number 03P76-25), i-STAT EG6+ (List Number 03P77-25), or i-STAT G3+ (List Number 03P78-26) cartridges.
  2. Identify if your cartridges belong to affected lot numbers including N25206, N25207, N25209, N25213, N25218, N25219, N25233, N25223A, or N25221.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: i-STAT EG7+ cartridge
Model / REF:
03P76-25
Lot Numbers:
N25206
N25207
N25209
N25213
N25218
N25219
N25233
UDI:
00054749000043

List Number: 03P76-25

Product: i-STAT EG6+ cartridge
Model / REF:
03P77-25
Lot Numbers:
N25223A
UDI:
00054749000050

List Number: 03P77-25

Product: i-STAT G3+ cartridge
Model / REF:
03P78-26
Lot Numbers:
N25221
UDI:
00054749005673

List Number: 03P78-26

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98635
Status: Active
Manufacturer: Abbott Point Of Care Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 440,700
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.