Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF ... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL)... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), ... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 20, 2024 Dr¿ger Perseus A500 Anesthesia Workstation Unexpected shutdown while operating on battery power. Class I Draeger Medical, Inc.
Mar 19, 2024 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, 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.