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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Roberts Home Medical LLC: Oxygen, Refrigerated Liquid USP Recalled for Manufacturing Deviations

Agency Publication Date: March 13, 2019
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Summary

Roberts Home Medical LLC is recalling 9 reservoirs of prescription-only Oxygen, Refrigerated Liquid USP due to deviations from Current Good Manufacturing Practice (CGMP) standards. These oxygen cylinders were filled at facilities in Rockville and Germantown, Maryland, and distributed to patients in Maryland, Virginia, and the District of Columbia. The recall was initiated because the product was not manufactured in compliance with safety and quality regulations, though no specific injuries have been reported. Consumers should identify if they have one of the 9 affected units by checking the lot numbers and manufacturer address on the cylinder.

Risk

Manufacturing deviations mean the product may not meet required purity or safety specifications. This could lead to a lack of efficacy in the medical oxygen therapy being provided to patients who rely on it for respiratory support.

What You Should Do

  1. Check the label on your oxygen cylinder for the following lot numbers: 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, or 01002100318.
  2. Verify if the manufacturer address on the label is Roberts Home Medical, Inc. in either Rockville, MD 20855 or Germantown, MD 20875.
  3. Contact your healthcare provider or pharmacist immediately to discuss obtaining a safe, alternative supply of medical oxygen.
  4. Return any unused product to the place of purchase for a refund and contact Roberts Home Medical LLC for further instructions on the return process.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxygen, Refrigerated Liquid USP, Rx only, cylinder
Model:
D-1002-2019
Lot Numbers:
01005100518
01010101918
01011101918
01007112118
01001100318
01007072518
01017120518
01011090518
01002100318

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82305
Status: Resolved
Manufacturer: Roberts Home Medical LLC
Manufactured In: United States
Units Affected: 9 Reservoirs
Distributed To: Maryland, Virginia, District of Columbia
Agency Last Updated: March 14, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.