FDA Device recall Z-2582-2025
i-STAT CG4+ cartridge (white)
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of i-STAT CG4+ cartridge (white) by Abbott Point, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2582-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-21 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Reason
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.
Identifiers
| code_info | List Number: 03P85-25. All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2582-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.