Class I U.S. Food and Drug Administration

Merit Medical Systems, Inc. 16F Dual Valved Splittable Sheath Introducer recall: 16F dual-valved splittable sheath introducer due to a design defect

Recall published 7 months ago

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 hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1577-2026
Published
April 1, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Merit Medical Systems, Inc.
Product type
Medical devices
Units affected
368,264
Distribution
Nationwide
Made in
United States
Lot / code info
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, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713, I2539714, I2539715, I2539717, I2561078, I2561079, I2561081, I2561082, I2573969, I2606642, I2606643, I2606644, I2606645, I2619459, I2621646, I2621647, I2621648, I2621649, I2621650, I2621651, I2621652, I2621653, I2642738, I2642739, I2642740, I2644031, I2644032, I2644033, I2644034, I2644036, I2661872, I2661873, I2661874, I2661875, I2661876, I2661877, I2708121, I2708122, I2708123, I2708124, I2720071, I2720074, I2720075, I2720076, I2720077, I2720078, I2720079, I2729938, I2729939, I2729940, I2729941, I2729942, I2729943, I2729944, I2729945, I2759253, I2759254, I2759255, I2759256, I2759257, I2759258, I2759260, I2759261, I2759268, I2759269, I2781492, I2781493, I2781494, I2781495, I2781496, I2781497, I2781498, I2781499, I2788883, I2788884, I2788885, I2788886, I2788887, I2788888, I2788889, I2788890, I2788891, I2788892, I2810292, I2810293, I2810294, I2810296, I2810297, I2841474, I2841475, I2849305, I2849306, I2854355, I2854356, I2854357, I2860217, I2860218, I2861568, I2861569, I2871785, I2871786, I2871787, I2883689, I2883691, I2890983, I2904247, I2904250, I2927630, I2927631, I2942563, I2942564, I2942565, I2942566, I2942567, I2942568, I2942569, I2942570, I2942571, I2942667, I2942669, I2988895, I2988896, I2988897, I3013245, I3013246, I3075993, I3075994, I3075995, I3075996, I3075997, I3083308, I3083309, I3083310, I3083312, I3083314, I3083317, I3098214, I3098256, I3127468, I3138237, I3138238, I3138239, I3138240, I3138241, I3138242, I3159773, I3159774, I3159776, I3159777, I3186218, I3257331
UPC codes
00884450522196

Products covered by this recall

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884450522196

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • FCL-174-00

Model or item number

On the rating label, the box or the instruction sheet.

  • FCL-174-00
  • B — REF

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Merit Medical Systems, Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Merit Medical Systems, Inc. — 1600 W Merit Pkwy, South Jordan, UT, 84095-2416

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Merit Medical Systems, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884450522196; lot code FCL-174-00; model number FCL-174-00, B — REF. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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