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Owen Mumford USA, Inc.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Owen Mumford USA, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (7)

FDA medical device enforcement actions by Owen Mumford USA, Inc.

Date Product Reason Class
May 26, 2021 Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with bui... Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mix... Class II
Jul 17, 2019 Petfine Auto Injector, REF 3310VET There is a possible assembly error on Autoject EI, lot number V14. This lot ... Class II
Jul 17, 2019 Autoject EI, REF AJ1310 There is a possible assembly error on Autoject EI, lot number V14. This lot ... Class II
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposur... Class II
Nov 6, 2017 Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... Device may potentially be compromised by water in end user packaging. Exposur... Class II
Dec 11, 2014 Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN... The dials in the Autopens are not working - the dial does not stay dialed, bu... Class II
Nov 24, 2014 Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 ... The syringe carrier is missing components: a damper and spring. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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