Z-1440-2017Class II

Eclipse Hypodermic Needle

Name: Z-1440-2017 Eclipse Hypodermic Needle
Creator: Becton Dickinson & Company
Published: 2016-12-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-12-20 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of Eclipse Hypodermic Needle on 2016-12-20. FDA classified it as Class II and gives the reason as "BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1440-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-20
Posted: 2018-10-11
Terminated: 2018-04-20
Recalling firm: Becton Dickinson & Co
Product: Eclipse Hypodermic Needle
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
Root cause tag: design
FDA root cause: Device Design
Action: BD sent a Product Advisory Notice and Business Reply Card dated December 29, 2016 via UPS Ground delivery to their affected customers.
Quantity in commerce: 263 mm units
Distribution: US Nationwide
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1440-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1440-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-10

Product code FMI

K161170Class IIBD Eclipse Hypodermic NeedleBecton, Dickinson and Company / cleared 2016-05-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)