Facility

Owen Mumford Sdn Bhd

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013143994
Establishment type	Manufacture Medical Device
Location	No. 19 & 21, Jalan Bioteknologi 3 Iskandar Puteri Johor, MY 79200
Registration status	Active · expires 2026
Parent company	OWEN MUMFORD LTD. (owner-operator 8021764)
Brand names	Autoject 2; Rebiject II; Fixed Needle

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Introducer, Syringe Needle
Product code KZH (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6920

Recalls & enforcement

Class IIOngoing2021-05-26
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Class IIOngoing2019-07-17
There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
Class IITerminated2017-11-06
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Class IITerminated2014-12-11
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
Class IITerminated2014-11-24
The syringe carrier is missing components: a damper and spring.

FDA inspections (2)

NAI2025-01-23
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2022-08-25
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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

Cite this record

RegWarden. “Owen Mumford Sdn Bhd (FEI 3013143994) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013143994-owen-mumford-sdn-bhd/

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