FDA Medical Device Recalls (openFDA)
Embecta Corp.: BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
- Recall number
- Z-2424-2024
- Recalling firm
- Embecta Corp.
- Product
- BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
- Status
- Open, Classified
- Initiated
- 2024-06-18
- Posted
- 2024-07-23
- Terminated
- not on file
- Reason
- BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
- Root cause
- Process control
- Action
- embecta* issued Urgent Medical Device Recall Letter on 6/18/24 via Fed'X to Pharmacist & Pharmacy Staff and End Users. Letter states reason for recall, health risk and action to take: 1. Review your product to see if it matches the specific Catalog (Ref) and Lot number listed above. Immediately discard all unused product into a sharps container. 2. If the affected product was previously used, follow up with a healthcare professional if there are any adverse reactions such as inflammation or redness of the skin. 3. Complete the online Customer Response Form whether or not you have any of the impacted materials so we may acknowledge your receipt of this notification: https://iqvia-response.my.site.com/mt/fca?cid=embc240004. Report any adverse health consequences experienced with the use of this product to embecta. If you require further assistance, please contact: Support US Contact Information Areas of Support Recall response support Phone: +1 650 540 3359 Mon-Fri 8:00am-5PM PST Email: embc-24-0004@iqvia.com Recall questions, customer response form, and product returns North American Customer Care Phone: 888-232-2737 Say Recall when prompted Mon Fri 8:30am-5:00pm EST Email: diabetes@embecta.com Product Complaints, Technical Questions *On April 1, 2022, BD completed the spinoff of its global diabetes care business into a separate, newly established company, Embecta Corp (embecta).
- Quantity
- 185900
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- GTIN: (01)10382903205513 Lot Number: 9044773 Expiry Date: 2024/02/29 *The Patient Counseling Sample Toolbox contains BD Nano" 2nd Gen Pen Needles and patient brochures, it has a marketing reference number of 6484755 and lot 3750144.
- 510(k) numbers
- ["K212015"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3022699058
- Firm city
- Franklin Lakes
- 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