Roberts Home Medical Recalls Refrigerated Liquid Oxygen Cylinders Due to CGMP Deviations
Roberts Home Medical LLC is voluntarily recalling 9 refrigerated liquid oxygen reservoirs due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Maryland, Virginia, and the District of Columbia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves CGMP deviations in a life-support medication (oxygen), which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.
Plain-English summary
Roberts Home Medical LLC has voluntarily initiated a recall of 9 refrigerated liquid oxygen reservoirs. The recall was initiated on December 19, 2018, and was classified as Class II by the U.S. Food and Drug Administration. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.
The affected product is Oxygen, Refrigerated Liquid USP, which is prescription-only and supplied in cylinders. The specific lots involved are 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, and 01002100318. The product does not have an expiration date but has an evaporation rate of approximately 60 days from the fill date, depending on the head pressure of the reservoir.
The product was distributed in Maryland, Virginia, and the District of Columbia. The recall status is currently terminated, with a termination date of May 1, 2019. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
- Manufacturer
- Roberts Home Medical LLC
- Category
- Drug — Oxygen Therapy
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot # 01005100518
- 01010101918
- 01011101918
- 01007112118
- 01001100318
- 01007072518
- 01017120518
- 01011090518
- 01002100318. No expiration date
Distribution
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