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

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

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

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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.

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