The Recall Desk
SevereFDA (Devices)·Z-1579-2026·Announced 2026-04-01

BioFlo DuraMax catheters recalled as Class I over sheath introducer defect

Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.

Plain-English summary

Merit Medical Systems, Inc. is recalling BioFlo DuraMax Catheters across 27 REF numbers. About 47,153 units were distributed worldwide, covering 43 US states and more than fifty other countries.

The 16F dual-valved splittable sheath introducer, due to a design defect, may not split as intended. This may result in hemorrhage, foreign bodies, procedure delay, embolization or thrombosis, impaired catheter function, and loss of vessel for future vascular access. The FDA has classified this recall as Class I, its most serious category.

Affected product is listed by REF, UDI-DI and lot number in the FDA enforcement record.

Facilities can identify affected catheters by the REF and lot numbers, and may contact Merit Medical Systems, Inc. for further information.

The recalled product

Product
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Hemodialysis catheter
Hazard
Affected units
47,153

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)

  • REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589
  • I3115469
  • I3314948
  • I3343030
  • H965103028021/A:00884450793213/I2985084
  • I3235297
  • I3302100
  • I3343023
  • H965103028021/EU:00884450840733/I3254932
  • H965103028031/A:00884450786215/I2890967
  • I2909607
  • I2909610
  • I2909613
  • I2922255
  • I2928443
  • I2928445
  • I2973185
  • I2975817
  • I2979931
  • I2979932

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Merit Medical Systems, Inc. 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 5 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · design defect

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