The Recall Desk
ModerateFDA (Devices)·Z-1366-2015·Announced 2015-04-08

Owen Mumford Autoject E1 Fixed Needle Device Recalled for Missing Components

Owen Mumford USA, Inc. is recalling 3,100 Autoject E1 Fixed needle devices because the syringe carrier is missing a damper and spring.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Owen Mumford USA, Inc. is recalling 3,100 units of the Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010. The recall involves Lot No. 5LW. The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.

The recall was initiated because the syringe carrier is missing components, specifically a damper and a spring. The FDA has classified this recall as Class II.

The affected products were distributed nationwide in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX. Consumers who have this product should stop using it and contact the manufacturer for instructions on how to proceed.

The recalled product

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.
Affected units
3,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 5LW

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically: