Class I U.S. Food and Drug Administration

Baxter Healthcare Corporation Hillrom Volara System P.circuit 5KIT AC, , Model/ recall: There have been reports of air and medication leakage from the nebulizer cup

Recall published 4 months ago

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

The hazard: Lead or heavy metal content

The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

What the notice says: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2551-2026
Published
July 8, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Baxter Healthcare Corporation
Product type
Medical devices
Units affected
13881 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
UPC codes
10887761981499

Products covered by this recall

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device

Check your product

The notice names 4 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.

  • 10887761981499

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 28
  • 2025 — 13881 units

Model or item number

On the rating label, the box or the instruction sheet.

  • REF M08474

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 Lead

Baxter Healthcare Corporation — The recall is about heavy metal content exceeding what U.S. law allows in a product children handle.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.
  3. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  4. Follow the remedy on this page — lead recalls almost always carry a full refund.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Baxter Healthcare Corporation — 1 Baxter Pkwy, Deerfield, IL, 60015-4625

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 Baxter Healthcare Corporation medical devices recalled?

There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10887761981499; lot code 28, 2025 — 13881 units; model number REF M08474. 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?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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