The Recall Desk
ModerateFDA (Devices)·Z-2585-2025·Announced 2025-09-24

i-STAT Cartridges Recalled for Lack of FDA Premarket Clearance

Abbott Point Of Care is recalling approximately 547,250 i-STAT cartridges nationwide because they lack FDA 510(k) premarket clearance for updated specifications, including revised sample types and measurement ranges.

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: Class II medical device recall issued due to lack of FDA 510(k) premarket clearance for updated device specifications. No adverse events or patient injuries have been reported.

Plain-English summary

Abbott Point Of Care Inc. is recalling approximately 547,250 i-STAT cartridges distributed nationwide. The recalled cartridges include the EG6+, EG7+, and CG8+ models, identified by List Number 03P77-25 with all lot numbers.

The cartridges were distributed and marketed without FDA 510(k) premarket clearance for updated device specifications. Specifically, the recalled cartridges lack clearance for revised sample types required for potassium and ionized calcium measurement, as well as updated measurement ranges for pH and PO2 tests.

Healthcare facilities, laboratories, and medical testing sites using these cartridges should immediately discontinue use and contact Abbott Point Of Care Inc. for instructions on device replacement or return procedures.

The recalled product

Product
i-STAT EG6+ cartridge. List Number: 03P77-25.
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Point-of-Care Testing Cartridge
Hazard
  • missing-premarket-clearance
  • unclearred-specifications

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: 03P77-25. All lot numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

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