i-STAT EG6+ cartridge — Class II medical device recall Z-2000-2026

Ongoing recall by Abbott Point Of Care Inc., reported 2026-05-06, distributed nationwide. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03

Recall number	`Z-2000-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Abbott Point Of Care Inc., Princeton, NJ, United States
Recall initiated	2026-04-01
Classified	2026-04-29
Reported by FDA	2026-05-06
Distributed	Nationwide (US)
Countries outside the US	AT, BD, BE, CA, CH, DE, ES, FI, FR, GB, IE, IT, LU, NL, NO, PL, PT, SE
UPC / GTIN / UDI-DI	`00054749000050`
Lot numbers	`N25223A`

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2000-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.