BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample… recallZ-2424-2024 · Embecta Corp. · initiated Jun 18, 2024
Class II Open, Classified All recalls posted in July 2024
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 Corp. 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
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.
FDA root cause category: Process control
What the company is doing
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: [email protected] 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: [email protected] 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).
Recall details
- Recall number
- Z-2424-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 18, 2024
- Posted by the FDA
- Jul 23, 2024
- Recalling firm
- Embecta Corp.
- Quantity
- 185900
- Product code
- FMI
- FDA submissions
- K212015
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
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.
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
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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