CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
i-STAT CG8+ cartridge recalled by Abbott Point Of Care
Abbott Point Of Care is recalling i-STAT CG8+ cartridge, distributed nationwide in the US. The recall was initiated on 21 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2583-2025
- FDA event ID
- 97443
- Recalling firm
- Abbott Point Of Care, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2025
- FDA classified
- 17 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Aug 2025 | Recall initiated by company | |
| 17 Sep 2025 | Classified by FDA | +27 days |
| 24 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
List Number: 03P88-25. All lot numbers.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97443This product is part of a recall event; the main page for the event is i-STAT EG6+ cartridge recalled by Abbott Point Of Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide | |
| CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
More recalls from Abbott Point Of Care
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT G3+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT CG4+ cartridge (white) recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
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