Compressed Oxygen Cylinders Recalled Due to Manufacturing Quality Deviations
Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II classification without reported illnesses, injuries, or hospitalizations. The manufacturing process deviations in this critical medical product represent a risk-of-harm situation where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen (Oxygen, Compressed USP, UN 1072) that were manufactured and distributed nationwide between May 10, 2023, and October 31, 2023. The cylinders are labeled in sizes C, D, E, H, M, and M6.
The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) standards during the manufacturing process. The FDA classified this as a Class II recall on November 16, 2023, following the firm's initial notification on November 9, 2023.
Healthcare providers and patients who received cylinders from the affected lots should contact Family Medical Supply Inc at 2011 W Cumberland St., Dunn, NC 28334, for instructions on return or replacement. Units should not be used until product quality can be verified.
The recall was terminated on August 8, 2025.
The recalled product
- Product
- Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
- Manufacturer
- Family Medical Supply Inc
- Affected units
- 26,657
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 (4)
- All lots manufactured and distributed May 10
- 2023
- through October 31
- 2023.
Distribution
Distributed nationwide across the United States.
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