--- title: "Merit Medical Systems, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Merit Medical Systems, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/merit-medical-systems-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Merit Medical Systems, Inc. recall records **91** reported ongoing 91 records in this archive. Latest source date May 8, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 8, 2026 FDA device enforcement ### [Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF...](https://isitonrecall.com/recall/fda-device-z-2517-2026-splashwire-hydrophilic-guide-wire-ref-mswstda35150-udi-di-codes-00884450529645-00884450529669-008844/) Due to unsealed portions of pouches. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, ... [Official source for Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2517-2026%22) Apr 2, 2026 FDA device enforcement ### [Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY](https://isitonrecall.com/recall/fda-device-z-2002-2026-philips-bridge-prep-kit-ref-k12-09098b-sterile-eo-rx-only/) catheter may experience resistance when being advanced over the guidewire Class II Reported ongoing Distribution: US Nationwide distribution in the state of CO. [Official source for Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2002-2026%22) Apr 2, 2026 FDA device enforcement ### [Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY](https://isitonrecall.com/recall/fda-device-z-2003-2026-philips-bridge-prep-kit-ref-k12-09098c-sterile-eo-rx-only/) catheter may experience resistance when being advanced over the guidewire Class II Reported ongoing Distribution: US Nationwide distribution in the state of CO. [Official source for Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2003-2026%22) Apr 2, 2026 FDA device enforcement ### [Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY](https://isitonrecall.com/recall/fda-device-z-2004-2026-philips-bridge-prep-kit-ref-k12-09098c-sterile-eo-rx-only/) catheter may experience resistance when being advanced over the guidewire Class II Reported ongoing Distribution: US Nationwide distribution in the state of CO. [Official source for Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2004-2026%22) Feb 13, 2026 FDA device enforcement ### [CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/...](https://isitonrecall.com/recall/fda-device-z-1575-2026-centrosflo-hemodialysis-catheters-ref-cenfp15k-a-cenfp15k-b-cenfp17k-a-cenfp19k-a-cenfp23k-a-cenfp27/) 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. Class I Reported ongoing Distribution: 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,... [Official source for CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1575-2026%22) Feb 13, 2026 FDA device enforcement ### [ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C](https://isitonrecall.com/recall/fda-device-z-1576-2026-proguide-chronic-dialysis-catheters-ref-dc01455550-c-dc21452419-c-dc21452419-ne5-c-dc21452823-ne5-c/) 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. Class I Reported ongoing Distribution: 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,... [Official source for ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC2145282...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1576-2026%22) Feb 13, 2026 FDA device enforcement ### [16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B](https://isitonrecall.com/recall/fda-device-z-1577-2026-16f-dual-valved-splittable-sheath-introducer-bulk-non-sterile-ref-fcl-174-00-b/) 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. Class I Reported ongoing Distribution: 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,... [Official source for 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1577-2026%22) Feb 13, 2026 FDA device enforcement ### [DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/...](https://isitonrecall.com/recall/fda-device-z-1578-2026-duramax-chronic-hemodialysis-catheter-ref-h787103028015-a-h787103028025-a-h787103028031-a-h787103028/) 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. Class I Reported ongoing Distribution: 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,... [Official source for DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1578-2026%22) Feb 13, 2026 FDA device enforcement ### [BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H9651030...](https://isitonrecall.com/recall/fda-device-z-1579-2026-bioflo-duramax-catheter-ref-h965103028011-a-h965103028021-a-h965103028021-eu-h965103028031-a-h965103/) 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. Class I Reported ongoing Distribution: 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,... [Official source for BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1579-2026%22) Dec 4, 2025 FDA device enforcement ### [Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN42...](https://isitonrecall.com/recall/fda-device-z-1123-2026-merit-medical-inflation-device-basixcompak-30-atm-bar-20-ml-reference-numbers-endo-an2030-b-in4130-c/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN41...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1123-2026%22) Dec 4, 2025 FDA device enforcement ### [Allwell Inflation Device, for angiographic use REF: IS-30-A](https://isitonrecall.com/recall/fda-device-z-1124-2026-allwell-inflation-device-for-angiographic-use-ref-is-30-a/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Allwell Inflation Device, for angiographic use REF: IS-30-A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1124-2026%22) Dec 4, 2025 FDA device enforcement ### [Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261](https://isitonrecall.com/recall/fda-device-z-1125-2026-merit-medical-custom-waste-management-kit-vascular-tray-ref-k10t-05261/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1125-2026%22) Dec 4, 2025 FDA device enforcement ### [Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-...](https://isitonrecall.com/recall/fda-device-z-1126-2026-merit-medical-custom-inflation-kit-ref-k05-00761f-k05-01717b-k05-02080d-k05-02090c-k05-02221-k05-023/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1126-2026%22) Dec 4, 2025 FDA device enforcement ### [Merit Medical , Custom Manifold Kit REF: K09-13203A](https://isitonrecall.com/recall/fda-device-z-1127-2026-merit-medical-custom-manifold-kit-ref-k09-13203a/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Merit Medical , Custom Manifold Kit REF: K09-13203A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1127-2026%22) Dec 4, 2025 FDA device enforcement ### [Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B](https://isitonrecall.com/recall/fda-device-z-1128-2026-merit-medical-custom-procedure-kit-reference-numbers-k12t-04270a-k12t-07956-k12t-10922b/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1128-2026%22) Dec 4, 2025 FDA device enforcement ### [Allwell Angioplasty Pack REF: IS-30-B1/B](https://isitonrecall.com/recall/fda-device-z-1129-2026-allwell-angioplasty-pack-ref-is-30-b1-b/) Inflation device handle may detach from the syringe during procedure. Class II Reported ongoing Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND... [Official source for Allwell Angioplasty Pack REF: IS-30-B1/B](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1129-2026%22) Aug 4, 2025 FDA device enforcement ### [PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP8...](https://isitonrecall.com/recall/fda-device-z-0533-2026-phd-hemostasis-valve-ref-in4802-k-in4802-t-in4918-a-in7802-c-in8802-c-in9802-in9802-a-k05-02166b-k05/) Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage. Class II Reported ongoing Distribution: US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, M... [Official source for PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K0...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0533-2026%22) Jul 25, 2025 FDA device enforcement ### [10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to ma...](https://isitonrecall.com/recall/fda-device-z-2553-2025-10fore-hemostasis-valve-catalog-number-udi-di-code-mapten4-00884450821305-mapten42-00884450832509-ma/) Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea [Official source for 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 0088445...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2553-2025%22) Jun 5, 2025 FDA device enforcement ### [High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C](https://isitonrecall.com/recall/fda-device-z-2293-2025-high-pressure-tubing-ref-502211002-hp9720e-c-hp9721e-c/) High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. Class II Reported ongoing Distribution: US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA. [Official source for High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2293-2025%22) Jun 5, 2025 FDA device enforcement ### [Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029](https://isitonrecall.com/recall/fda-device-z-2294-2025-custom-tubing-kit-ref-k04-00417-k04-00963-k04-01029/) High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. Class II Reported ongoing Distribution: US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA. [Official source for Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2294-2025%22) ## Reasons in these listed records - Due to unsealed portions of pouches. - catheter may experience resistance when being advanced over the guidewire - 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. - Inflation device handle may detach from the syringe during procedure. These examples come from this result page and are not a ranking of every recall reason. ## Checking Merit Medical Systems, Inc. ### Is there a recall on merit medical systems, inc. right now? This archive contains 91 records, including 91 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Merit Medical Systems, Inc.](https://isitonrecall.com/check/?q=Merit%20Medical%20Systems%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)