Medical DeviceJun 24, 2026
Merit Medical Systems Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes recall — FDA Z-2517-2026
Due to unsealed portions of pouches.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Recall history in this database
Classification mix: Class I: 5, Class II: 1.
Medical DeviceApr 1, 2026
Merit Medical Systems CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B recall — FDA Z-1575-2026
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,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C recall — FDA Z-1576-2026
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,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF recall — FDA Z-1577-2026
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,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A recall — FDA Z-1579-2026
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,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A recall — FDA Z-1578-2026
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,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Merit Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.