Official recall notice

FDA DeviceClass IINotable

FDA Recall: PIE PAK Models: P2HC-A, P2HC-S, P2HC

Recall date
2026-03-04
FDA class
Class II

Why it was recalled

Hazard

Lack of 510K clearance

Recommended action

What to do

11202 units

Product description

Lack of 510K clearance

Verify with the official notice →
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