i-STAT EG7+ cartridge — Class II medical device recall Z-1999-2026
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-1999-2026 |
|---|---|
| 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 | 00054749000043 |
| Lot numbers | N25206, N25207, N25209, N25213, N25218, N25219, N25233 |
Product
i-STAT EG7+ cartridge; List Number: 03P76-25;
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-1999-2026. 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.