FDA Devices recall · Reported July 29, 2015
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
Western / Scott Fetzer Company recalled Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, o… - a critical-severity action.
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, o… was recalled by Western / Scott Fetzer Company in July 29, 2015. Reason: The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen c…. Check the official notice for the remedy. Verify recall #Z-2069-2015 with the FDA Devices before acting.
The recall
Western / Scott Fetzer Company issued this critical-severity FDA Devices recall-The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen c….
- Critical
- severity level
- 163K units
- affected scope
- Class I
- classification
- July 29, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2069-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
Reason for recall
The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2069-2015 |
| Date reported | July 29, 2015 |
| Date initiated | January 31, 2015 |
| Recalling firm | Western / Scott Fetzer Company |
| Firm location | Westlake, OH |
| Affected scope | 162,678 units |
| Distribution | Worldwide Distribution -- US, including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2069-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026