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
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TU... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... Class I Baxter Healthcare Corporation
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEON... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 16, 2024 Inspire Model 3028, IV Implantable Pulse Generator There is a potential manufacturing defect which can lead to electrical leakage in the sensing cir... Class I Inspire Medical Systems Inc.
May 15, 2024 Ventilator HAMILTON-C6, PN: 160021 Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnec... Class I Hamilton Medical AG
May 8, 2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... Reports of patient burns. Class I Megadyne Medical Products, Inc.
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... Class I Thoratec Corp.
May 7, 2024 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Plum 360/A+ spare batteries. Item Number: SUB0000864. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 1, 2024 Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk ... Class I Getinge Usa Sales Inc
Apr 30, 2024 ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Oper... Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Pa... Class I ZOLL Medical Corporation
Apr 29, 2024 Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 29, 2024 Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... Teleflex received reports indicating an infrequent condition that, when not identified and correc... Class I ARROW INTERNATIONAL Inc.
Apr 18, 2024 Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the... Class I OptumHealth Care Solutions LLC
Apr 8, 2024 Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Num... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-7073... Potential of the nozzle separating during patient use. Class I Vyaire Medical, Inc.
Apr 8, 2024 Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ590... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 1, 2024 OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 11... Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alar... Class I Philips Respironics, Inc.
Mar 26, 2024 BiPAP V30 Auto Ventilator, Part Number 1111178 Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 26, 2024 BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and ... Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 26, 2024 Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... Class I Medtronic Navigation, Inc.
Mar 26, 2024 BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbe... Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 25, 2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... Class I SonarMed Inc
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 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 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 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 FL3 (5PK)REF H74908... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation

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.