EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Summary
The FDA issued a Class II for EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannula by embecta Medical II LLC. Reason: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices..
Details
Source
Device Recall
External ID
Z-3180-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Lot/Code Info: No UDI/All products labeled "for Investigational Use Only"
Quantity Affected: 3000 Final Count (in EA)
Reason for Recall
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-26
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
embecta Medical II LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (embecta Medical II LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does embecta Medical II LLC have FDA actions?
embecta Medical II LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3180-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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