i-STAT CG8+ cartridge — Class II medical device recall Z-2583-2025
Ongoing recall by Abbott Point Of Care Inc., reported 2025-09-24, distributed nationwide. Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample t
| Recall number | Z-2583-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Point Of Care Inc., Princeton, NJ, United States |
| Recall initiated | 2025-08-21 |
| Classified | 2025-09-17 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 8,962,450 units |
Product
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2583-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.