RegWardenFDA facility compliance records
Recall

Class II — Owen Mumford USA, Inc.

Recalling firmOWEN MUMFORD LTD.
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe syringe carrier is missing components: a damper and spring.
ProductAutoject 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.
Quantity3,100
DistributionUS nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Initiated2014-11-24
Classified2015-04-02
Terminated2017-07-31
Recall numberZ-1366-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Owen Mumford USA, Inc. (Z-1366-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70665/

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