Z-0508-2021Class II

BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a...

Name: Z-0508-2021 BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a...
Creator: Becton Dickinson & Company
Published: 2020-10-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-10-23 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number... on 2020-10-23. FDA classified it as Class II and gives the reason as "Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0508-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-11-27
Terminated: 2023-09-08
Recalling firm: Becton Dickinson & Co
Product: BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: BD consignees and distributors notified on October 23, 2020 via hard copy letter sent via Federal Express (FedEx) and/or email, when available. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number specified in this notification and discard all product subject to the recall. 2. Share this recall notification with pharmacy staff at all applicable pharmacy locations and display the letter where it is visible to all to ensure awareness of this recall Distributors are requested to identify their customers and provide BD a customer list. BD will notify these customers via FedEx. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement order, accordingly. 4. This recall is being conducted at the wholesaler/hospital/retail level only. There is no need to notify users who may have already purchased the device, as the product itself is not defective and presents no risk to users. Actions Taken by BD: " Replacement product will be provided for all discarded inventory. Contact Information: If you require further assistance, please contact: BD Contact Information: BD Customer/Technical Support (844) 823-5433 Mon Fri 8:30am - 5:00pm (CST
Quantity in commerce: 2,881,200 units
Distribution: Nationwide
Product codes and lots: Batch Number: 9352052 Exp. Date: 20241231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0508-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0508-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27

Product code FMI

K162516Class IIBD Pen NeedleBecton, Dickinson and Company / cleared 2016-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)