Z-1366-2015Class II

Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector...

Name: Z-1366-2015 Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector...
Creator: Owen Mumford USA, Inc.
Published: 2014-11-24
License: https://open.fda.gov/license/

Owen Mumford USA, Inc. / initiated 2014-11-24 / Terminated / root cause: manufacturing process

FDA source

Owen Mumford USA, Inc. began a recall of Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by... on 2014-11-24. FDA classified it as Class II and gives the reason as "The syringe carrier is missing components: a damper and spring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1366-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-24
Posted: 2015-04-02
Terminated: 2017-07-31
Recalling firm: Owen Mumford USA, Inc.
Product: Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
Product code: KZH Introducer, Syringe Needle
Reason for recall: The syringe carrier is missing components: a damper and spring.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall letters were issued to customers via FedEx. The letter instructed the customer to check their shelves for the product and specific lot number and to visually inspect (pictures included in letter of a correctly assembled device and one with the missing spring & damper) the device if they have the affected lot. A form was included which was to be filed out and returned.
Quantity in commerce: 3,100
Distribution: US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Product codes and lots: Lot No. 5LW

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1366-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1366-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code KZH

K945660Class IIAutoject 2Owen Mumford USA, Inc. / cleared 1995-08-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)