Class I U.S. Food and Drug Administration

Medline Industries, LP Reprocessed Siemens Acuson AcuNav Diagnostic Ultrasound recall: These lots of reprocessed catheters may contain small particles of residual

Recall published 8 months ago

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

The hazard: Choking hazard

The product sheds or contains pieces small enough to choke a young child, which is why the remedy is removal rather than an added warning label.

What the notice says: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

Why it matters: Small parts can come off this product, or it contains pieces small enough to block a young child’s airway. Children under three explore with their mouths, and a blocked airway leaves minutes, not hours.

Symptoms and when to call a doctor

If a child is coughing forcefully, let them cough — that clears an object better than anything you can do. If they cannot cough, cry or breathe, call 911 and begin back blows and chest thrusts for an infant, or abdominal thrusts for an older child, if you are trained. After any episode where the object was swallowed rather than spat out, have the child checked: a piece can lodge in the oesophagus without obvious symptoms.

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-1325-2026
Published
February 18, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
511
Distribution
Nationwide
Made in
United States
Lot / code info
10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905
UPC codes
10197344026500, 10197344026517

Products covered by this recall

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

Check your product

The notice names 2 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.

  • 10197344026500
  • 10197344026517

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 Choking

Medline Industries, LP — The product sheds or contains pieces small enough to choke a young child, which is why the remedy is removal rather than an added warning label.

  1. Take the product away from any child under three and check the floor and furniture for pieces that have already come off.
  2. Refresh infant and child choking first aid if it has been a while; the Red Cross and most hospitals run short courses.
  3. Inspect similar items from the same range or set, since detaching parts usually point to a production problem rather than one bad unit.
  4. Do not hand it down to a younger sibling or drop it at a charity shop.

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.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • 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.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

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 Medline Industries, LP medical devices recalled?

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10197344026500, 10197344026517. 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 any child under three and check the floor and furniture for pieces that have already come off.

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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