Recall of i-STAT EG6+ Cartridges by Abbott Point of Care Inc.
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Abbott Point of Care Inc. is recalling certain lots of i-STAT EG6+ cartridges due to potential inaccuracies in blood gas results that could lead to harmful medical interventions, affecting over 30,000 units worldwide.
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.
Recall Article
What Happened
Abbott Point of Care Inc. is initiating a recall because approximately 7.6% of cartridges from specific lots of i-STAT EG6+ may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. This could result in misdiagnosis, potentially triggering unnecessary or harmful medical interventions.
Which Products Are Affected
The affected product is the i-STAT EG6+ cartridge with List Number: 03P77-25, UDI-DI: 00054749000050, and Lot number: N25223A. A total of 30,775 units are affected, with 25,625 in the US and 5,150 outside the US. The products were distributed nationwide in the US and to countries including 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
Affected parties should follow the initial firm notification, which was sent via letter, for instructions on how to handle the recalled products. This recall is voluntary and firm-initiated.
Why This Matters
This recall matters because inaccurate test results could lead to unnecessary medical treatments or delays in proper care, potentially affecting patient safety in healthcare settings.
Source
This information is from the FDA recall notice, recall number Z-2000-2026.
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 (1,386 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.