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Velvet Screen SPF 50 (Grace & Fire) - Inconsistent SPF Protection (2025)

Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.

Class IIModerate

FDAAug 22, 2025Nationwide• GRACE & FIRE PTY LTD

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.

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Velvet Screen SPF 50 (Grace & Fire) - Inconsistent SPF Protection (2025)

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)

Honey Balsamic Salad Kit (Taylor Farms) – undeclared allergens (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)