FDA · Class II · September 23, 2026

embecta Medical II recall: EWO_02512 and 1 more product

embecta Medical II LLC is recalling EWO_02512 and 1 more product – 4300 Final Count (in EA); 3000 Final Count (in EA). The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 26, 2023. Distributed nationwide.

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

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	EWO_02512 and 1 more product
Brand	embecta Medical II
Company	embecta Medical II LLC
Type	Medical devices
Classification	Class II
Recall date	July 26, 2023
Published by FDA	September 23, 2026
Quantity	4300 Final Count (in EA); 3000 Final Count (in EA)
Recall ID	99593

As listed by FDA

Recalled products (2)

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
FDA recall number
Z-3179-2026
Codes, lots and dates
No UDI/All products labeled "for Investigational Use Only"
Quantity
4300 Final Count (in EA)
Classification
Class II
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
FDA recall number
Z-3180-2026
Codes, lots and dates
No UDI/All products labeled "for Investigational Use Only"
Quantity
3000 Final Count (in EA)
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99593
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Parsippany, NJ, United States

Why it was recalled

The reason the FDA lists: “Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.”

Where it was sold

Nationwide. Distribution as the FDA records it: “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 to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99593, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is embecta Medical II EWO_02512 recalled?

Yes. embecta Medical II LLC recalled it on July 26, 2023; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

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

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.