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Browse Device Recalls

125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 125 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 125 FDA device recalls.

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DateProductReasonClassFirm
Apr 10, 2025 CADD Solis HSPCA Pump Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter... Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, ... There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VI... There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 ... Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... Class I Smiths Medical ASD, Inc.
Apr 10, 2025 CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO... Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions... Class I Smiths Medical ASD, Inc.
Feb 14, 2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... Class II Smiths Medical ASD, Inc.
Feb 14, 2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... Class II 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 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 Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/... Affected devices have a smaller diameter than expected and may potentially result in inadequate v... 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 28, 2024 smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, R... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, Inc.
Oct 28, 2024 smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-... Smiths Medical has identified a potential for ingress of fluid into the device during reprocessin... Class II Smiths Medical ASD, 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 26, 2024 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... Class II Smiths Medical ASD, Inc.
Jan 7, 2020 Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for ... Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. Class II Smiths Medical ASD, Inc.
Jan 7, 2020 Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases... Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have bro... Class II 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.