Food, drugs, devices › Owen Mumford USA, Inc.
Device recall: Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patie
FDA enforcement event 70665 is a device recall by Owen Mumford USA, Inc. of Marietta, GA, initiated 24 Nov 2014 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 31 Jul 2017. Initiation: voluntary: firm initiated. Owen Mumford USA, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Owen Mumford USA, Inc., Marietta, GA.
Reason for recall
"The syringe carrier is missing components: a damper and spring."
Distribution
"US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1366-2015 | 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. | 3,100 | Class II | Terminated | 8 Apr 2015 |
Context
Other enforcement events for Owen Mumford USA, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 May 2021 | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. | Device | Class II | 1 |
| 17 Jul 2019 | Autoject EI, REF AJ1310 | Device | Class II | 2 |
| 6 Nov 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, | Device | Class II | 2 |
| 11 Dec 2014 | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The produ | Device | Class II | 1 |
All 5 events for Owen Mumford USA, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The syringe carrier is missing components: a damper and spring."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.