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Browse Device Recalls

288 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 288 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 288 FDA device recalls.

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DateProductReasonClassFirm
Oct 7, 2025 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... Class II Trividia Health, Inc.
Sep 25, 2025 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... Due to an identified manufacturing defect involving coating material lifting within the catheter'... Class I BALT USA, LLC
Sep 4, 2025 XERF EFFECTOR 60. Electrosurgical unit. Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result... Class II Lutronic Corporation
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 8, 2025 The Medline General Surgery Tray is customized to meet requirements of the ho... Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 1, 2025 JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside ... Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potentia... Class II North American Rescue LLC.
Apr 30, 2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the ... A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S p... Class II Beckman Coulter Mishima K.K.
Apr 21, 2025 BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... Class II Becton Dickinson Infusion Therapy Systems, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Pol... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Feb 13, 2025 smiths medical ProPort Plastic Venous Access System, Implantable Venous Acces... The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... Class I Smiths Medical ASD, Inc.
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 29, 2024 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... Class II SEASPINE ORTHOPEDICS CORPORATION
Oct 21, 2024 Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 o... Class II Siemens Healthcare Diagnostics, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code R... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Sep 24, 2024 medex Arterial Kit 1/EA, Product Code REF MX7827 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Jun 7, 2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD 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.