Class II U.S. Food and Drug Administration

Ventec Life Systems, Inc. HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Recall published 25 days ago

Labeling; Oxygen Cylinders do not contain required medical gas labeling

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3221-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Ventec Life Systems, Inc.
Product type
Medical devices
Units affected
21 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI:00850018761369/Serial #s: 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKMA005G8 24IKMA005AP 24IKMA005QB 24IKMA005Q4 24IKMA005PM 24IKMA005QJ 24IKMA005QX 24IKMA005PJ 24IKMA005SW 24IKMA005RB 24IKMA00612 24IKMA0067E 24IKMA0066L 24IKMA0068U 24IKMA00685 24IKMA006AQ 24IKMA006B7 24IKMA006BG
UPC codes
00850018761369

Products covered by this recall

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00850018761369

Serial number

On the rating plate, often next to the date of manufacture.

  • 24IKMA00532 24IKMA0053M 24IKMA0054N 24IKM

Package size

Match the net weight or the piece count on the front of the pack.

  • 0066 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Ventec Life Systems, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Ventec Life Systems, Inc. — 22002 26th Ave Se, Bothell, WA, 98021-4903

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ventec Life Systems, Inc. medical devices recalled?

Labeling; Oxygen Cylinders do not contain required medical gas labeling Labeling; Oxygen Cylinders do not contain required medical gas labeling

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00850018761369. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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