FDA Medical devices recall ·
i-STAT EG6+ cartridge recall
- Recall number
- Z-2585-2025
- Date
- (initiated August 21, 2025)
- 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
- 547,250 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
i-STAT EG6+ cartridge. List Number: 03P77-25.
Why was it recalled?
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
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. All lot numbers.
Distribution
US Nationwide distribution.
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-2585-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.