CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

i-STAT EG6+ cartridge recalled by Abbott Point Of Care

Abbott Point Of Care is recalling i-STAT EG6+ cartridge, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;

Quantity recalled30775 units (25625 US, 5150 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2000-2026
FDA event ID: 98635
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 1 Apr 2026
FDA classified: 29 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Apr 2026	Recall initiated by company
29 Apr 2026	Classified by FDA	+28 days
6 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

Product as listed by the FDA

i-STAT EG6+ cartridge; List Number: 03P77-25;

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

Nationwide

Questions about this recall

Is i-STAT EG6+ cartridge recalled?

Yes. Abbott Point Of Care recalled i-STAT EG6+ cartridge on 1 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2000-2026.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott Point Of Care

All 31

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
6 May 2026Device	CLASS II	i-STAT G3+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT CG8+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT CG4+ cartridge (white) recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide

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