Owen Mumford USA, Inc.
Owen Mumford USA, Inc. has 5 FDA enforcement events on this register (7 product records) between 2014 and 2021: 5 device; the busiest year was 2014 with 2.
0% of its events are Class I; the most common class is Class II (5). 2 events are listed as ongoing; the recalling firm's address is in GA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 26 May 2021 | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. | Device | Class II | 1 | Ongoing |
| 17 Jul 2019 | Autoject EI, REF AJ1310 | Device | Class II | 2 | Ongoing |
| 6 Nov 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. | Device | Class II | 2 | Terminated |
| 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 product is a non-sterile automatic subcutaneous injection device which delivers insulin. | Device | Class II | 1 | Terminated |
| 24 Nov 2014 | 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. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Owen Mumford USA, Inc. had?
5 enforcement events (7 product records) on this register, 2014–2021: 5 device.
Are any Owen Mumford USA, Inc. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Owen Mumford USA, Inc. recalls?
5 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.