The Recall Desk
ModerateFDA (Devices)·Z-2583-2025·Announced 2025-09-24

Blood gas CG8+ cartridges recalled for lacking updated premarket clearance

i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 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 CG8+ cartridge, list number 03P88-25, is being recalled across all lot numbers. The recall covers 8,962,450 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 CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — In Vitro Diagnostic
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: 03P88-25. All lot numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category