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i-STAT EG7+ Cartridge (Abbott) – Sample Type Issue (2025)

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.

Low

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

Low

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

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i-STAT EG7+ Cartridge (Abbott) – Sample Type Issue (2025)

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

i-STAT EG6+ Cartridge (Abbott) – Sample Type Issue (2025)

Medline Valve Pack (Unknown) – Catheter Shape Retention (2025)

Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

i-STAT CG4+ Cartridge (Abbott) – Measurement Range Issue (2025)

Frontier 16mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Venclose digiRF Generator (Bard) – Wiring Detection Feature (2025)

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

i-STAT CG8+ Cartridge (Abbott) – Sample Type Problem (2025)

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

VISIONIST CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ESSENTIO DR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

PROPONENT DR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE DR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ACCOLADE SR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

MST ArcDUO Ophthalmic Knife (MicroSurgical) – Contamination Risk (2025)

ALTRUA 2 SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

ALTRUA 2 DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)