Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Testing Failures
Oklahoma Respiratory Care Inc is recalling 861 cylinders of compressed oxygen due to missing identity and purity testing and documentation gaps.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations regarding testing and documentation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Oklahoma Respiratory Care Inc is recalling 861 cylinders of OXYGEN, COMPRESSED USP MEDICAL GAS. The affected products are available in E Cylinder (680L), D Cylinder (425L), and M6 Cylinder (165L) containers and were distributed in Oklahoma. The recall covers lots distributed between January 1, 2011, and October 18, 2011.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to perform identity or purity testing on incoming oxygen gas and lacked proper documentation. The FDA has classified this recall as Class II.
Consumers and healthcare providers who have these specific oxygen cylinders should stop using them and contact Oklahoma Respiratory Care Inc for further instructions or a replacement.
The recalled product
- Product
- OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
- Manufacturer
- Oklahoma Respiratory Care Inc
- Category
- Drug — Medical Gas
- Affected units
- 861
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 (3)
- All lots distributed January 1
- 2011 - October 18
- 2011.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Oklahoma Respiratory Care Inc
See all →- ModerateOklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Purity Failures
FDA (Drugs) · 2013-07-31
Same hazard · documentation gap
See all →- ModerateCompounded parenteral nutrition bags recalled over insufficiently documented cleaning step
FDA (Drugs) · 2025-07-23
- HighPregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure
FDA (Devices) · 2023-11-01
- ModerateEye drops Equate and private-label brands recalled for manufacturing documentation deficiency
FDA (Drugs) · 2023-07-19
- ModerateSiemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors
FDA (Devices) · 2021-03-03