FDA Recall of Abbott i-STAT EG7+ Cartridges Due to Inaccurate Test Results
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Abbott Point of Care Inc. is recalling specific lots of i-STAT EG7+ cartridges because they may report inaccurate pCO2 and pH results, potentially leading to misdiagnosis and unnecessary medical interventions.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The recall involves i-STAT EG7+ cartridges that may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. This could make the blood gas appear as if the patient is in severe respiratory acidosis, potentially triggering unnecessary or harmful interventions.
Which Products Are Affected
The affected products are i-STAT EG7+ cartridges with List Number: 03P76-25, UDI-DI: 00054749000043, and specific lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233. A total of 369,650 units are affected, including 150,875 in the US and 218,775 outside the US. The distribution is nationwide in the United States and also includes countries such as Canada, Austria, Bangladesh, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, Mauritius, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
What You Should Do
Consumers and users should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Abbott Point of Care Inc., for further instructions on the recall.
Why This Matters
This recall is significant because inaccurate test results could lead to improper medical decisions, potentially causing harm from unnecessary treatments or delays in correct care, affecting patient safety in healthcare settings.
Source
FDA recall notice Z-1999-2026; attribution to FDA (U.S. Food and Drug Administration).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,474 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.