The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0263-2020·Announced 2019-11-13

FDA Recalls Autoject EI Medical Devices Due to Possible Assembly Error

Owen Mumford USA is recalling 1,510 units of Autoject EI devices due to a possible assembly error. The lot was distributed to 13 states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Autoject EI medical devices, reference number AJ1310, manufactured by Owen Mumford USA, Inc. The recall involves 1,510 units from lot number V14. The agency identified a possible assembly error associated with this specific lot.

The affected lot was packed into two distinct products: AJ 1310 (lot number V14) and AN 3310VET, which is branded as Petfine Auto Injector (batches V14.V976 and V14.W107). The recall covers distribution in Florida, Louisiana, South Carolina, California, New Jersey, Texas, North Carolina, Colorado, New Hampshire, Kentucky, New York, Missouri, and Pennsylvania.

Consumers and healthcare providers should stop using the affected devices and contact Owen Mumford USA, Inc. for further instructions or a replacement. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product
Autoject EI, REF AJ1310
Manufacturer
Owen Mumford USA, Inc.
Category
Medical Device — Injection Device
Hazard
Affected units
1,510

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/Unit Number: V14

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by Owen Mumford USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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