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

[pending] BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H

Pending LLM rewrite. Source: FDA_DEVICE Z-1579-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

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 — Devices

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.

Related recalls

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