Merit Medical Systems, Inc.
70 federal recalls on file, showing the 5 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Merit Medical Systems, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-17FDA-DeviceClass II10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
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.
- 2025-08-20FDA-DeviceClass IICustom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
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.
- 2025-08-20FDA-DeviceClass IICustom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
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.
- 2025-08-20FDA-DeviceClass IICustom 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.
- 2025-08-20FDA-DeviceClass IIHigh 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.
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