FDA Medical Device Recalls (openFDA)
Owen Mumford USA, Inc.: 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.
- Recall number
- Z-1366-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-11-24
- Posted
- 2015-04-02
- Terminated
- 2017-07-31
- Reason
- The syringe carrier is missing components: a damper and spring.
- 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
- 3,100
- Distribution
- US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
- Lot, serial or model codes
- Lot No. 5LW
- 510(k) numbers
- ["K945660"]
- PMA numbers
- not on file
- Product code
- KZH
- Firm FEI
- 1000219614
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28