FDA Medical devices recall ·
i-STAT EG6+ cartridge recall
- Recall number
- Z-2000-2026
- Date
- (initiated April 1, 2026)
- Company / brand
- Abbott Point Of Care Inc.
400 College Rd E, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 30775 units (25625 US, 5150 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
List Number: 03P77-25; UDI-DI: 00054749000050; Lot number: N25223A;
Distribution
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2000-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.