EWO_02512 (Catalog number 320550) recallZ-3179-2026 · embecta Medical II LLC · initiated Jul 26, 2023
Class II Open, Classified All recalls posted in September 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from embecta Medical II LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-3179-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 26, 2023
- Posted by the FDA
- Sep 16, 2026
- Recalling firm
- embecta Medical II LLC
- Quantity
- 4300 Final Count (in EA)
- Product code
- FMI
- FDA submissions
- K212015
- 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 description
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Code information (models, lots, serial numbers)
No UDI/All products labeled "for Investigational Use Only"
Other devices under the same FDA submission
3 devices cleared under K212015 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD Nano 2nd Gen 320574Becton, Dickinson And Company · Needle, hypodermic, single lumen65 reports
- BD Nano 2nd Gen 320551Becton Dickinson Pen Limited · Needle, hypodermic, single lumen14 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99593).
- Z-3180-2026 · Open, ClassifiedEWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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