Blood gas EG7+ cartridges recalled for lacking updated premarket clearance
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is a regulatory clearance gap for updated claims rather than any defect described in the product.
Plain-English summary
The i-STAT EG7+ cartridge, list number 03P76-25, is being recalled across all lot numbers. The recall covers 6,115,950 units distributed nationwide in the United States.
The recall was issued for lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect the updated sample type for potassium and ionized calcium and the measurement ranges for pH and PO2. The FDA classified the action as Class II. The notice does not describe a defect in the cartridges.
Laboratories and hospitals using these cartridges should follow the manufacturer's instructions.
The recalled product
- Product
- i-STAT EG7+ cartridge. List Number: 03P76-25.
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- regulatory-clearance
- in-vitro-diagnostic
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- List Number: 03P76-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22