Z-1244-2023Class II

BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in...

Name: Z-1244-2023 BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in...
Creator: Becton Dickinson & Company
Published: 2023-02-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-02-01 / Open, Classified / root cause: sterility

FDA source

Becton Dickinson & Company began a recall of BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number... on 2023-02-01. FDA classified it as Class II and gives the reason as "Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1244-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-10
Recalling firm: Becton Dickinson & Co
Product: BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Product code: FMF Syringe, Piston
Reason for recall: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: BD issued Urgent Medical Device Recall Letter to US Distributors/Wholesalers and Customer notification template on 2/1/23 via Federal Express (FedEx) and/or email, when available. OUS letters issued . Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy all affected products subject to the recall following your institution's process of destruction. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a customer letter to all customers to advise them of this field action notification on BD's behalf. An example of a customer communication is attached for your reference. 3. Complete the attached Distributor 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 credit, if required Credit will be provided for all destroyed product following receipt of the completed Distributor Response Form. Contact: North American Regional Complaint Center Phone: 1-844-88D-LIFE (1-844-823-5433) Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce: 1,472,400 units
Distribution: Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.
Product codes and lots: GTIN: N/A Lot Number: 2010670, Exp. Date:2031581 Lot Number: 2052365, Exp. Date:20270531

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1244-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1238-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1239-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1240-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1241-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1242-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1243-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10
Z-1244-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-10

Product code FMF

K190054Class IIBD Insulin SyringeBecton, Dickinson and Company / cleared 2019-10-21

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)