Official recall notice

FDA DeviceClass IINotable

FDA Recall: REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

Labeling; Oxygen Cylinders do not contain required medical gas labeling

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Product description

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Affected products

UDI:00850018761352/Serial #s: 24IKMA0029J and 24IKMA002CM

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