RegWardenFDA facility compliance records
Facility

OWEN MUMFORD USA, INC.

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

Activity by year

FDA actions on record by year2014: 2 recalls; 2017: 1 recalls; 2019: 1 recalls, 1 inspections; 2021: 1 recalls2’14’15’161’17’182’19’201’21’22’23’24’25’26
  • Recalls (5)
  • Inspections (1)

Devices registered here (1)

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 (1)

  • NAI2019-03-05
    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.

Related

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 USA, INC. (FEI 1000219614) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000219614-owen-mumford-usa-inc/

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