Agency classClass IOur severity:Severe FDA (Devices)·Z-1577-2026·Announced 2026-04-01

Merit 16F splittable sheath introducer recalled as Class I bulk product

Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 the 16F Dual Valved Splittable Sheath Introducer, bulk non-sterile, REF FCL-174-00/B. About 368,264 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 carries UDI-DI 00884450522196, across an extensive list of lot numbers beginning I2362705.

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

The recalled product

Product: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Manufacturer: Merit Medical Systems, Inc.
Category: Medical Device — Vascular access
Hazard: design-defect
sheath-splitting-failure
hemorrhage-risk
vascular-access-loss
class-i-recall
Affected units: 368,264

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: FCL-174-00/B:00884450522196/I2362705
I2370091
I2370711
I2370712
I2377840
I2377841
I2391548
I2397290
I2415120
I2417400
I2417401
I2417402
I2428656
I2428657
I2428658
I2428659
I2469204
I2469205
I2469206
I2469207

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 →

Same manufacturer · Merit Medical Systems, Inc.

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