Lower riskMedical device recall · FDA · Published August 21, 2025
Abbott i-STAT EG6+ Cartridge Recall: Lack of 510(k) Clearance
Abbott recalls i-STAT EG6+ cartridges due to lack of 510(k) premarket clearance for updated potassium and calcium measurements. No immediate action needed as this is a regulatory issue, not a safety hazard.
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.
Take action
Contact the company
📍Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607
✎ GovInfoNow plain-language explainer
Abbott is recalling i-:STAT EG6+ cartridges because they lack proper regulatory approval for updated potassium and calcium measurements. This does not pose a safety risk to users but requires correction to meet regulatory standards. Read more at govinfonow.com/recall/51554-abbott-i-stat-eg6-cartridge-recall-lack-of-510-k.
“Abbott i-STAT EG6+ Cartridge Recall: Lack of 510(k) Clearance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51554-abbott-i-stat-eg6-cartridge-recall-lack-of-510-k. Based on FDA recall #Z-2585-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2585-2025%22&limit=1).
The FDA announced on 2025-08-21 that Abbott Point Of Care Inc. is recalling i-STAT EG6+ cartridges due to a lack of required premarket clearance. This Class II voluntary recall affects approximately 547,250 units distributed nationwide.
How to tell if you have it
Brand: Abbott
Product: i-STAT EG6+ cartridge
List Number: 03P77-25
Lot codes: All lot numbers
Quantity: 547,250 units
The hazard
The recall addresses the 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, according to the FDA.
Context
GovInfoNow's records show Abbott Point Of Care Inc. has 8 other recalls on record since 2017-09-12. Other recent recalls of similar products include Abbott i-STAT EG6+ Cartridges May Show Wrong Blood Gas Results (2026-04-01), Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance (2025-08-21) and Abbott i-STAT EG7+ Cartridges May Give Higher Calcium Results If Stored Too Long (2020-12-22). Other recent recalls of similar products include Medline Syringes Recall: 510(k) Clearances Rescinded for Safety (2026-02-25), Medline Angiography Kits Recall: 510(k) Clearances Rescinded (2026-02-25) and Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine Measurement Errors (2026-03-18).
How to tell if you have this one
Check for i-STAT EG6+ cartridges with List Number 03P77-25. All lot numbers are affected. This recall is for regulatory compliance, not a safety issue.
Brand
Abbott
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-2583-2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300; List Number: 03P88-25. All lot numbers.
8,962,450 units
Z-2584-2025
i-STAT EG7+ cartridge. List Number: 03P76-25.; List Number: 03P76-25. All lot numbers.
6,115,950 units
Z-2585-2025
i-STAT EG6+ cartridge. List Number: 03P77-25.; List Number: 03P77-25. All lot numbers.
547,250 units
Based on the official FDA remedy
What to do — step by step
Check Regulatory Status
Verify if your i-STAT EG6+ cartridges have the required 510(k) clearance for potassium and calcium measurements.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2585-2025 (August 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2585-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.