The Recall Desk
ModerateFDA (Devices)·Z-3180-2026·Announced 2026-09-23

Embecta Medical Recalls Pen Needles Labeled for Investigational Use Only

Embecta Medical II LLC is recalling pen needles labeled 'For Investigational Use Only' that were inadvertently distributed as commercially marketed devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/distribution error where investigational devices were distributed as commercial products. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Embecta Medical II LLC is recalling EWO_02513 (Catalog number 320122) Nano Un-Cannulated Demo Samples. The recall involves 3,000 units of pen needles that were labeled 'For Investigational Use Only' but were inadvertently distributed as commercially marketed devices.

The affected products were distributed nationwide in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, and MO. The agency has classified this as a Class II recall.

Consumers who have these specific pen needles should stop using them and contact the manufacturer for further instructions.

The recalled product

Product
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Manufacturer
embecta Medical II LLC
Category
Medical Device — Needles
Hazard
Affected units
3,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Related recalls

Same hazard · mis labeling

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