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O-Two Medical Technologies, Inc.

Complete recall history across all FDA and CPSC categories — 6 total recalls

O-Two Medical Technologies, 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 (6)

FDA medical device enforcement actions by O-Two Medical Technologies, Inc.

Date Product Reason Class
Feb 12, 2019 e500 Automatic Transport Ventilator, Model Number 01EVE500 There is a potential for the unit to catch fire due to one of the screen reta... Class I
Feb 12, 2019 e600 Automatic Transport Ventilator, Model Number 01EVE600 There is a potential for the unit to catch fire due to one of the screen reta... Class I
Feb 12, 2019 e700 Automatic Transport Ventilator, Model Number 01EVE700 There is a potential for the unit to catch fire due to one of the screen reta... Class I
May 14, 2018 O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model... Higher levels of nitrous oxide delivered than specification Class II
Sep 30, 2015 Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s... For lack of evidence to validate effectiveness of sterilization dose, O-Two M... Class II
Jun 23, 2015 O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01... Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the ... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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