Merit Medical Systems, Inc. recalls 16F Dual Valved Splittable Sheath Introducer (bulk
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF:FCL-174-00/BREF UDI-DI/Lot190 affected lotsI2370091I2370711I2370712I2377840I2377841I2391548I2397290I2415120
+182 more
I2417400I2417401I2417402I2428656I2428657I2428658I2428659I2469204I2469205I2469206I2469207I2473119I2485668I2485669I2485670I2485671I2485672I2485673I2485674I2485675I2496785I2496787I2496790I2516610I2516611I2516612I2516613I2516614I2516615I2539710I2539711I2539713I2539714I2539715I2539717I2561078I2561079I2561081I2561082I2573969I2606642I2606643I2606644I2606645I2619459I2621646I2621647I2621648I2621649I2621650I2621651I2621652I2621653I2642738I2642739I2642740I2644031I2644032I2644033I2644034I2644036I2661872I2661873I2661874I2661875I2661876I2661877I2708121I2708122I2708123I2708124I2720071I2720074I2720075I2720076I2720077I2720078I2720079I2729938I2729939I2729940I2729941I2729942I2729943I2729944I2729945I2759253I2759254I2759255I2759256I2759257I2759258I2759260I2759261I2759268I2759269I2781492I2781493I2781494I2781495I2781496I2781497I2781498I2781499I2788883I2788884I2788885I2788886I2788887I2788888I2788889I2788890I2788891I2788892I2810292I2810293I2810294I2810296I2810297I2841474I2841475I2849305I2849306I2854355I2854356I2854357I2860217I2860218I2861568I2861569I2871785I2871786I2871787I2883689I2883691I2890983I2904247I2904250I2927630I2927631I2942563I2942564I2942565I2942566I2942567I2942568I2942569I2942570I2942571I2942667I2942669I2988895I2988896I2988897I3013245I3013246I3075993I3075994I3075995I3075996I3075997I3083308I3083309I3083310I3083312I3083314I3083317I3098214I3098256I3127468I3138237I3138238I3138239I3138240I3138241I3138242I3159773I3159774I3159776I3159777I3186218I3257331
What the firm is doing
On 2/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: A picture of the 16F Dual-Valved Splittable Sheath Introducer is attached to help you identify the product. Place this notice and the picture on or near the affected product in your inventory (if applicable). Discontinue the use of the 16F Dual-Valved Splittable Sheath Introducer and destroy the sheath introducer at the point of use. Ensure that applicable personnel within your organization are made aware of this field action. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Complete and return the customer response form via email to response@merit.com If you have any questions concerning this communication, contact the firm's Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri. On 4/2/2026, revised notices were mailed to customers that included stickers to be placed on affected devices to ensure awareness of the recall.
DistributionShow detailsHide
Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1577-2026
- FDA 510(k) clearance · K043438The device's official FDA premarket clearance record
- FDA device classification · DYBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1340The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Merit Medical Systems, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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