Reported Apr 1, 2026 · Ongoing
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Merit Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile)
- REFFCL-174-00/B
- Lot codes and dates
- REFUDI-DI/Lot:
- FCL-174-00/B
191 of 191 codes
00884450522196/I2362705I2370091I2370711I2370712I2377840I2377841I2391548I2397290I2415120I2417400I2417401I2417402I2428656I2428657I2428658I2428659I2469204I2469205I2469206I2469207I2473119I2485668I2485669I2485670I2485671I2485672I2485673I2485674I2485675I2496785I2496787I2496790I2516610I2516611I2516612I2516613I2516614I2516615I2539710I2539711I2539713I2539714I2539715I2539717I2561078I2561079I2561081I2561082I2573969I2606642I2606643I2606644I2606645I2619459I2621646I2621647I2621648I2621649I2621650I2621651
- Amount recalled
- 368,264
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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