Grace Healthcare Recalls Compressed Oxygen Cylinders Due to cGMP Deviations
Grace Healthcare Medical recalls 35,838 compressed oxygen cylinders due to current Good Manufacturing Practice deviations. Check your cylinder labels and lot dates.
Use caution until it’s fixed
cGMP deviations
Contact the company
What happened, in plain English
Grace Healthcare Medical, Inc. is recalling Compressed Oxygen USP UN 1072 packaged in various medical gas cylinders due to current Good Manufacturing Practice (cGMP) deviations. The affected products were manufactured and distributed between 04/01/2019 and 04/09/2021. Approximately 35,838 cylinders are involved in this nationwide recall. Read more at govinfonow.com/recall/36210-grace-healthcare-recalls-compressed-oxygen-cylinders-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/36210-grace-healthcare-recalls-compressed-oxygen-cylinders-due-to-cgmp-deviations · Updated October 10, 2026 · FDA enforcement record: FDA #D-0355-2021
Cite this page
“Grace Healthcare Recalls Compressed Oxygen Cylinders Due to cGMP Deviations.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36210-grace-healthcare-recalls-compressed-oxygen-cylinders-due-to-cgmp-deviations. Based on FDA recall #D-0355-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2021%22&limit=1).
Why it’s dangerous
The recall is due to cGMP deviations, which means the manufacturing process did not meet federal quality standards. While the specific nature of the deviation is not detailed in this record, such deviations can potentially affect the purity, pressure integrity, or safety of medical gas products used for breathing.
Who’s affected
This recall affects individuals and facilities in the USA who purchased or use compressed oxygen from Grace Healthcare Medical during the specified manufacturing period. Patients requiring supplemental oxygen may be impacted if they possess these specific cylinders.
How to tell if you have this one
Look for oxygen cylinders labeled as M6, C, D, E, M, or H Medical Gas Cylinders. The product is Rx only and distributed by Grace Healthcare Medical, Inc., located in Gulfport, MS. Check if the cylinder was manufactured between 04/01/2019 and 04/09/2021.
- Brand
Grace Healthcare Medical- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Grace Healthcare Medical, Inc. at 228-863-3331 for further instructions regarding the recall.
Check Cylinder Labels
Verify if your cylinder matches one of the labeled types (M6, C, D, E, M, H) and falls within the manufacturing date range of 04/01/2019 to 04/09/2021.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0355-2021 (April 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0355-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.