Official recall notice

FDA DeviceClass IINotable

FDA Recall: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Qu

Recall date
2026-09-23
FDA class
Class II

Why it was recalled

Hazard

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Product description

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Affected products

No UDI/All products labeled "for Investigational Use Only"

Verify with the official notice →
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