FDA Medical Device Recalls (openFDA)
embecta Medical II LLC: EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
- Recall number
- Z-3180-2026
- Recalling firm
- embecta Medical II LLC
- Product
- EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
- Status
- Open, Classified
- Initiated
- 2023-07-26
- Posted
- 2026-09-16
- Terminated
- not on file
- Reason
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- 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
- 3000 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.
- Lot, serial or model codes
- No UDI/All products labeled "for Investigational Use Only"
- 510(k) numbers
- ["K213478"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3022699058
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28