Linde Recalls 283 Oxygen Cylinders Due to Calibration Deviations
Linde Gas LLC is recalling 283 oxygen cylinders in Ohio because expired calibration equipment may have caused incorrect filling levels.
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 2/5 (Moderate).
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, but the source text does not report any illnesses, injuries, or deaths. The hazard is a theoretical risk of improper filling levels due to equipment calibration lapses, fitting the criteria for a moderate severity score.
Plain-English summary
Linde Gas LLC is recalling 283 cylinders of LifeGas OXYGEN COMPRESSED UN1072 USP. The product was distributed only within Ohio, and no federal government, foreign, or Canadian consignees received the product. The affected lots are identified as 117H201 and 117H202.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, pressure gages, vacuum gages, and thermometers used in the process had surpassed their calibration expiry periods. This lapse may have resulted in the overfilling or underfilling of the oxygen cylinders.
Consumers who possess these specific lots of oxygen cylinders should stop using them and contact Linde Gas LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
- Manufacturer
- Linde Gas LLC
- Category
- Drug — Compressed Gas
- Affected units
- 283
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 (1)
- LOT#: 117H201 LOT#: 117H202
Distribution
Distributed in 1 state:
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