Z-2007-2019Class II

3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

Name: Z-2007-2019 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Creator: Becton Dickinson & Company
Published: 2019-02-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-02-01 / Terminated

FDA source

Becton Dickinson & Company began a recall of 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 on 2019-02-01. FDA classified it as Class II and gives the reason as "The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2007-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-01
Posted: 2019-07-22
Terminated: 2020-06-11
Recalling firm: Becton Dickinson & Co
Product: 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Product code: FMF Syringe, Piston
Reason for recall: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 2/1/19 were sent to customers.
Quantity in commerce: 460,800
Distribution: The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
Product codes and lots: Lot Number 8303571

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2007-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2007-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2008-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22

Product code FMF

K980987Class IIBecton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-06-11

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)