Class I U.S. Food and Drug Administration

Medline Industries, LP Reprocessed Electrophysiology Catheters and Ultrasound recall: Expansion of RES 98277. Specific lots of reprocessed catheters may contain

Recall published 4 months ago

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

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: Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

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-2615-2026
Published
July 8, 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
3
Distribution
Nationwide
Made in
United States
Lot / code info
Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
UPC codes
10197344043767

Products covered by this recall

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.

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.

  • 10197344043767

Model or item number

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

  • 401206RH
  • 401305RH
  • 401206RH - UDI-DI 10197344043767

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. Follow the remedy on this page — most choking recalls are refunded in full.
  3. Refresh infant and child choking first aid if it has been a while; the Red Cross and most hospitals run short courses.
  4. Inspect similar items from the same range or set, since detaching parts usually point to a production problem rather than one bad unit.

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.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.
  • 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.

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?

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10197344043767; model number 401206RH, 401305RH, 401206RH - UDI-DI 10197344043767. 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.

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