Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brand
- Abbott Point Of Care
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abbott Point Of Care
- Product type
- Point-of-care diagnostic cartridge
- Model numbers
- List Number: 03P88-25. All lot numbers.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 21, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The i-STAT CG8+ cartridge is used with the i-STAT handheld analyzer to perform rapid blood tests at point of care. It is part of a family of cartridges for electrolyte, pH, and gas measurements.
Why This Is Dangerous
The absence of 510(k) clearance for updated cartridge configurations could lead to incorrect or unvalidated test results if used clinically.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics rely on these cartridges for rapid testing. The recall interrupts testing workflows and may require validation steps to ensure accurate results with alternative cartridges.
Practical Guidance
How to identify if yours is affected
- 1. Locate List Number on cartridge packaging and leaflet.
- 2. Confirm List Number is 03P88-25.
- 3. Verify that all lot numbers are covered under this recall.
- 4. Immediately stop using affected cartridges.
- 5. Follow Abbott recall instructions and contact a healthcare professional for guidance.
Where to find product info
FDA recall page Z-2583-2025 and Abbott Point Of Care recall notices.
What timeline to expect
Recall notification indicates immediate stopping of use. Replacement or remediation details will be provided by Abbott; timelines are not specified in
If the manufacturer is unresponsive
- Document all correspondence with Abbott and the healthcare facility.
- Escalate to hospital compliance or patient safety officers if needed.
- File a formal complaint with the FDA if there is no timely remediation.
How to prevent similar issues
- Verify clearance status for each cartridge batch before stocking.
- Use only FDA-cleared configurations of i-STAT cartridges.
- Maintain an updated recall log and supplier communication.
- Train staff to quarantine and label recalled lots.
Documentation advice
Keep recall notices, packaging, and any correspondence. Photograph lot numbers and List Numbers for records.
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Product Details
List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300. Distribution: US Nationwide. Quantity: 8,962,450 units. Sold at: Not specified in recall notice.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- List Number 03P88-25
- US nationwide distribution
- Active recall as of 2025-08-21 (FDA)
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