medical MODERATE Updated 2026-09-23

embecta Medical II LLC recalls EWO_02512 (Catalog number 320550) For Investigational Use O

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Recalled Product

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: No UDI/All products labeled "for Investigational Use Only"

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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