EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
FDA Recall Z-3179-2026 · Posted 2026-09-16
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Recalling Firmembecta Medical II LLC
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2023-07-26
Product Quantity4300 Final Count (in EA)
Reason for Recall
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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