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Browse Device Recalls

140 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 140 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 140 FDA device recalls.

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DateProductReasonClassFirm
Feb 13, 2026 DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A,... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-17... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Feb 13, 2026 CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, C... 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, w... Class I Merit Medical Systems, Inc.
Dec 4, 2025 Allwell Angioplasty Pack REF: IS-30-B1/B Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical , Custom Manifold Kit REF: K09-13203A Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Number... Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Dec 4, 2025 Allwell Inflation Device, for angiographic use REF: IS-30-A Inflation device handle may detach from the syringe during procedure. Class II Merit Medical Systems, Inc.
Aug 4, 2025 PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, ... Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, lea... Class II Merit Medical Systems, Inc.
Jul 25, 2025 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821... Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or other... Class II Merit Medical Systems, Inc.
Jun 5, 2025 Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05... High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Jun 5, 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 resu... Class II Merit Medical Systems, Inc.
Jun 5, 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 resu... Class II Merit Medical Systems, Inc.
Jun 5, 2025 Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K... High pressure tubing may relax over time causing it to partially separate from the connector resu... Class II Merit Medical Systems, Inc.
Mar 14, 2025 Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners,... Update to IFU to provide additional information related to risk with device over-rotation and mu... Class II Merit Medical Systems, Inc.
Mar 14, 2025 Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, Sterile... Update to IFU to provide additional information related to risk with device over-rotation and mu... Class II Merit Medical Systems, Inc.
Jan 27, 2025 Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators... Class II Merit Medical Systems, Inc.
Aug 30, 2024 Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal I... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Inser... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Inserti... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angi... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis V... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 30, 2024 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographi... Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. Class II Merit Medical Systems, Inc.
Aug 19, 2024 IntelliSystem Inflation Device, REF: IN1525/D Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 StabiliT TOUCH Syringe, REF: IN8VCF/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8140/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 BlueFIRE Inflation Device, REF: IN10140 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixSKY Inflation Device, REF: SKY1802 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 12, 2024 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Aug 12, 2024 Custom Procedure Kit, REF: K12T-11077 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.