Home / Recalls / Merit Medical Systems, Inc. / Z-1576-2026

Z-1576-2026 Class I Ongoing

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

FDA device recall Z-1576-2026 was initiated by Merit Medical Systems, Inc. on February 13, 2026 and is designated Class I. 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 cathe… The recall status is ongoing. Affected quantity: 131.

Recall Details

Product Type
Devices
Report Date
April 1, 2026
Initiation Date
February 13, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
131

Product Description

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

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.

Distribution Pattern

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

Code Information

REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169; DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C:00884450697924/H2600164, H2628890; DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C:00884450697948/H2630602; DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229

Other recalls by Merit Medical Systems, Inc.

  • Z-2517-2026 Class II — Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445052 (May 8, 2026)
  • Z-2003-2026 Class II — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY (April 2, 2026)
  • Z-2002-2026 Class II — Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY (April 2, 2026)
  • Z-2004-2026 Class II — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY (April 2, 2026)
  • Z-1578-2026 Class I — DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H7 (February 13, 2026)
  • Z-1577-2026 Class I — 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-0 (February 13, 2026)
  • Z-1579-2026 Class I — BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU (February 13, 2026)
  • Z-1575-2026 Class I — CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENF (February 13, 2026)
  • Z-1126-2026 Class II — Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05- (December 4, 2025)
  • Z-1125-2026 Class II — Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 (December 4, 2025)

FDA data resources