Class 2 Device Recall BD Nano 2nd Gen Pen Needles 32G X 4mm (Investigational Use)

• Date Initiated by Firm: July 26, 2023
• Date Posted: September 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3179-2026
• Recall Event ID: 99593
• 510(K)Number: K212015
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
• Code Information: No UDI/All products labeled "for Investigational Use Only"
• FEI Number: 3022699058
• Recalling Firm/ Manufacturer: embecta Medical II LLC; 300 Kimball Dr Ste 300; Parsippany NJ 07054-2184
• For Additional Information Contact: Heather Reed; 978-387-4086
• Manufacturer Reason for Recall: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
• FDA Determined 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 in Commerce: 4300 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMI