CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano recalled

embecta Medical II is recalling EWO_02512 (Catalog number 320550) For Investigational Use Only Nano, distributed nationwide in the US. The recall was initiated on 26 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNo UDI/All products labeled "for Investigational Use Only"

Quantity recalled4300 Final Count (in EA)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3179-2026
FDA event ID: 99593
Recalling firm: embecta Medical II, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jul 2023
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Jul 2023	Recall initiated by company
16 Sep 2026	Classified by FDA	+1148 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution 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, MO.

Nationwide Alabama Arizona California Connecticut Florida Georgia Indiana Kentucky Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Hampshire New Jersey New York Ohio Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution 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, MO.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99593

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide

More recalls from embecta Medical II

All 2

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,208

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	DuoGlide Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	EWO_02513 (Catalog number 320122) For Investigational Use Only Nano recalled	embecta Medical II	Other	Nationwide
23 Sep 2026Device	CLASS I	Power-Trialysis Short-Term Straight Dialysis Catheter recalled	Bard Access Systems	Other	50 states
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), Guidewire recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide