HIGH
FDA DEVICE
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems
catheter may
Merit Medical Systems Recalls
16 recalls found for Merit Medical Systems. Check if any of your products are affected.
HIGH
FDA DEVICE
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems
catheter may
HIGH
FDA DEVICE
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems
catheter may
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical ProGuide 16F Dialysis Sheath Introducer Recalled Worldwide in 2026 (131 Units)
Merit Medical Systems recalled 131 units of the ProGuide chronic dialysis catheter introducer worldwide after a design defect could prevent the device from splitting as intended. The defect may cause hemorrhage, retained foreign bodies, and delays to procedures. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.
Merit Medical Systems
16F dual-valved
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical BioFlo DuraMax Catheter Recall 2026: 47,153 Units Worldwide
Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit
Merit Medical Systems
16F dual-valved
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical CentrosFLO Hemodialysis Catheters Recalled for 35,591 Units (2026)
Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.
Merit Medical Systems
16F dual-valved
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical 16F Dual-Valved Splittable Sheath Introducer Recalled for 368,264 Units Worldwide (202
Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for instructions.
Merit Medical Systems
16F dual-valved
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical's DuraMax 16F Hemodialysis Catheter Recalled For Splittable Sheath Defect (2026)
Merit Medical Systems recalled 21,591 DuraMax chronic hemodialysis catheters worldwide. The devices use a 16F dual-valved splittable sheath introducer that may not split as intended, risking hemorrhage and procedure delays. Clinicians should stop using the devices immediately and follow the recall instructions.
Merit Medical Systems
16F dual-valved
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Systems Recalls Angioplasty Packs Over Detachment Hazard
Merit Medical Systems recalled 328,000 angioplasty packs on December 4, 2025, due to a risk of the inflation device handle detaching during procedures. The recall affects devices distributed worldwide, including states across the U.S. Healthcare providers and patients must stop using the devices immediately.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Recalls Inflation Device Due to Detachment Hazard
Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Recalls Custom Manifold Kit Due to Detachment Risk
Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Recalls Vascular Tray Over Detaching Handle Hazard
Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Recalls Inflation Kits Due to Handle Detachment Hazard
Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Inflation Device Recalled Over Handle Detachment Risk
Merit Medical Systems recalled 4,163,123 inflation devices on December 4, 2025, due to a risk that the handle may detach during use. This defect poses a high hazard to patients and healthcare providers. Consumers should stop using the device immediately and follow the manufacturer’s instructions for returns.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard
Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.
Merit Medical Systems
Inflation device
Health & Personal Care
HIGH
FDA DEVICE
Merit Medical 10Fore Hemostasis Valve Recalled Due to Foreign Body Risk
Merit Medical Systems recalled 447 10Fore Hemostasis Valves following a manufacturing defect that may cause foreign bodies in the fluid pathway. The silicone quad ring may be deformed or damaged during use, posing serious health risks. Patients and providers should stop using the device immediately and follow recall instructions.
Merit Medical Systems
Due to
Brand Statistics
Total Recalls
16
Pages
1