Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance
Abbott recalls i-STAT CG4+ white cartridges due to missing 510(k) premarket clearance for updated lactate and pH/PO2 measurements. No immediate action needed.
Lower-risk recall
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Contact the company
What happened, in plain English
Abbott is recalling i-STAT CG4+ white cartridges because they lack proper premarket clearance for updated lactate and pH/PO2 measurements. This recall does not pose a safety risk to users. Read more at govinfonow.com/recall/51557-abbott-i-stat-cg4-cartridge-recall-lack-of-premarket-clearance.
Source Summary by GovInfoNow · govinfonow.com/recall/51557-abbott-i-stat-cg4-cartridge-recall-lack-of-premarket-clearance · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2582-2025
Cite this page
“Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51557-abbott-i-stat-cg4-cartridge-recall-lack-of-premarket-clearance. Based on FDA recall #Z-2582-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2025%22&limit=1).
Why it’s dangerous
The cartridges lack 51:0(k) premarket clearance for updated sample types and measurement ranges. This means they were not approved for the specific lactate and pH/PO2 testing they perform. However, the recall does not indicate any safety risk to users.
Who’s affected
Users of i-STAT CG4+ white cartridges may be affected. Healthcare professionals using these cartridges for lab testing are most at risk.
How to tell if you have this one
Check for i-STAT CG4+ white cartridges with list number 03P85-25. All lot numbers are affected.
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Cartridge Details
Verify the list number 03P85-25 and white color for affected cartridges.
Where it went and when
Where it was distributed
Distributed nationwide.
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.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-2582-2025 (August 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2582-2025 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.