FDA Medical devices recall ·

REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870… recall

Recall number
Z-3223-2026
Date
(initiated July 28, 2026)
Company / brand
Ventec Life Systems, Inc.
22002 26th Ave Se, Bothell, WA, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
25 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve

Why was it recalled?

Labeling; Oxygen Cylinders do not contain required medical gas labeling

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI:00850018761376/ Serial #s: 25EKMA00BAC 25EKMA009L3 25EKMA009CM 25EKMA009J8 25GKMA00077 25GKMA0007B 25GKMA0009Z 25GKMA0004U 25GKMA000CS 25GKMA000CR 25GKMA000CX 25GKMA000D0 25GKMA000LL 25GKMA000N1 25GKMA000UD 25GKMA000D1 25GKMA000TN 25GKMA000D2 25GKMA000UC 25GKMA000LK 25GKMA000UA 25GKMA000UB 25GKMA000UE 25GKMA000CY 25GKMA000UF

Distribution

US Nationwide distribution in the states of FL, IA, OH, NE, TN.

States: Florida Iowa Nebraska Ohio Tennessee

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-3223-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.