Class I U.S. Food and Drug Administration

Medline Industries, LP Reprocessed Biosense Webster Soundstar eco Diagnostic 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

This is a choking-hazard recall, aimed at children under three who cannot clear an obstruction themselves.

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-1324-2026
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
94
Distribution
Nationwide
Made in
United States
Lot / code info
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
UPC codes
10197344157297, 10197344157303, 10197344157273, 20197344157287, 10197344157280

Products covered by this recall

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

Check your product

The notice names 7 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.

  • 10197344157297
  • 10197344157303
  • 10197344157273
  • 20197344157287
  • 10197344157280

Lot or batch code

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

  • EP250724 EP250808
  • EP250724 EP250808 — 94

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 — This is a choking-hazard recall, aimed at children under three who cannot clear an obstruction themselves.

  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.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

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 10197344157297, 10197344157303, 10197344157273; lot code EP250724 EP250808, EP250724 EP250808 — 94. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls