The Recall Desk
CriticalFDA (Devices)·Z-1322-2026·Announced 2026-02-18

Reprocessed electrophysiology catheters recalled over residual material particles

Medline is recalling 48 reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters because these lots may contain small particles of residual material.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters are being recalled by Medline Industries, LP. The record lists the affected catalog numbers, beginning 401211RH, 401222RH, 401223RH, 401226RH and 401227RH, with the full list set out in the enforcement record.

The record states these lots of reprocessed catheters may contain small particles of residual material. It states that 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. The record notes this is an expansion of recall Z-2610/2614-2025.

The record lists 48 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.

Facilities should quarantine affected stock and follow Medline's instructions.

The recalled product

Product
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 40143
Manufacturer
Medline Industries, LP
Category
Medical Device — Electrophysiology catheter
Hazard
Affected units
48

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Medline Industries, LP

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Same hazard · residual material

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