Class I U.S. Food and Drug Administration

Medline Industries, LP Reprocessed St. Jude Supreme and Response 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

Small parts that can detach prompted this recall. The test the CPSC applies is whether a piece fits inside a cylinder roughly the size of a young child’s throat.

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-1322-2026
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
48
Distribution
Nationwide
Made in
United States
Lot / code info
401211RH UDI-DI 10197344043736 Lot EP250317; 401222RH UDI-DI 10197344043712 Lot EP250317; 401223RH UDI-DI 10197344043705 Lot EP250317; 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 Lot EP250317; 401261RH UDI-DI 10197344043651 Lot EP250317; 401306RH UDI-DI 10197344043620¿ Lot EP250317; 401309RH UDI-DI 10197344043613 Lot EP250317; 401312RH UDI-DI 10197344043583¿ Lot EP250307; 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317; 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317; 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317; 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317; 401442RH UDI-DI 10197344044245 Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 Lot EP250307; 401449RH UDI-DI 10197344044290 Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 Lot EP250307; 401994RH UDI-DI 10197344044542 Lot EP250317; 402012RH UDI-DI 10197344043835 Lots EP250307 EP250317; 402004RH UDI-DI 10197344044566 Lots EP250307 EP250317; 402010RH UDI-DI 10197344044597 Lots EP250307 EP250317; 402008RH UDI-DI 10197344044573 Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317 ***Updated 5/18/26*** LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH
UPC codes
10197344043736, 10197344043712, 10197344043705, 10197344043699, 10197344043682, 10197344043668, 10197344043651, 10197344043620, 10197344043613, 10197344043583, 10197344043491, 10197344043484, 10197344043460, 10197344043439, 10197344044245, 10197344044252, 10197344044283, 10197344044290, 10197344044306, 10197344044313

Products covered by this recall

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

Check your product

The notice names 23 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.

  • 10197344043736
  • 10197344043712
  • 10197344043705
  • 10197344043699
  • 10197344043682
  • 10197344043668
  • 10197344043651
  • 10197344043620
  • 10197344043613
  • 10197344043583
  • 10197344043491
  • 10197344043484
  • 10197344043460
  • 10197344043439
  • 10197344044245
  • 10197344044252
  • 10197344044283
  • 10197344044290
  • 10197344044306
  • 10197344044313

Lot or batch code

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

  • EP250317
  • EP250307 EP250317
  • EP250307

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 — Small parts that can detach prompted this recall. The test the CPSC applies is whether a piece fits inside a cylinder roughly the size of a young child’s throat.

  1. Take the product away from any child under three and check the floor and furniture for pieces that have already come off.
  2. Do not hand it down to a younger sibling or drop it at a charity shop.
  3. Follow the remedy on this page — most choking recalls are refunded in full.
  4. Refresh infant and child choking first aid if it has been a while; the Red Cross and most hospitals run short courses.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.

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 10197344043736, 10197344043712, 10197344043705; lot code EP250317, EP250307 EP250317, EP250307. 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?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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