Z-3179-2026Class II

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

Name: Z-3179-2026 EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity...
Creator: embecta Medical II LLC
Published: 2023-07-26
License: https://open.fda.gov/license/

embecta Medical II LLC / initiated 2023-07-26 / Open, Classified

FDA source

Recall record

Recall number: Z-3179-2026
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-26
Posted: 2026-09-16
Recalling firm: embecta Medical II LLC
Product: EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
FDA root cause: Nonconforming Material/Component
Action: On July 26, 2023, Embecta Medical II LLC ( subsidiary of Becton, Dickinson and Company 'BD's) issued a recall notification to consignees via email. Embecta ask consignees to take the following actions: 1. Immediately review your inventory for the specific Catalog (Ref) numbers listed above. If it is labeled with a "For investigational Use Only" statement, discard the product. 2. Share this advisory notification with anyone in your facility/office who may have received the product to ensure they are also aware of this advisory. 3. Identify all patients that may have received the affected product as defined in this notification. Provide a customer letter to all patients to advise them of this advisory notification on BD's behalf. An example of a patient communication is attached for your reference. 4.Complete the attached Customer Response Form whether or not you have any of the impacted material so that we may acknowledge your receipt of this notification.
Quantity in commerce: 4300 Final Count (in EA)
Distribution: 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.
Product codes and lots: No UDI/All products labeled "for Investigational Use Only"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3179-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3179-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16
Z-3180-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code FMI

K212015Class IIBD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company / cleared 2021-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)