Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
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) AIRE-CUF TRACHY T... 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) 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) TTS NEONATAL TRAC... 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 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... Class II Integra LifeSciences Corp.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM 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) 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 Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales 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) 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 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales 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 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 a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Cod... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales 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 28, 2024 CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularize... Grafts were found to have been approved, released, shipped and implanted with an invalid test res... Class II Artivion, Inc
May 28, 2024 (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 C... Grafts were found to have been approved, released, shipped and implanted with an invalid test res... Class II Artivion, Inc
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 LIH Influence check settings for Lipemia are incorrect which may result patient samples being rep... Class II Beckman Coulter Inc.
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Soft... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 27, 2024 Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Sof... During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... Class II Hitachi America, Ltd., Particle Therapy Division
May 24, 2024 WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation flu... Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set... Class II WOM World Of Medicine AG
May 24, 2024 Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COV... Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Autho... Class II CUE HEALTH INC
May 23, 2024 HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... Class II Howmedica Osteonics Corp.
May 23, 2024 Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 621... The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision... Class II Howmedica Osteonics Corp.
May 23, 2024 Surgical Image Guidance Functionality, software used with NGENUITY 3D Visuali... After surgery initiation, while using surgical image guidance, if significant eye rotation/moveme... Class II Alcon Research LLC
May 22, 2024 Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the f... Potential for inaccurate fetal heart rate measurements when monitoring multiples. Class II Philips North America Llc
May 22, 2024 Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes... Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation sur... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 22, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoas... Class II Beckman Coulter, Inc.
May 22, 2024 DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) ... Class II Beckman Coulter, Inc.
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R ... Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sh... Class II Merit Medical Systems, Inc.
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Endo Model SL Tibial Components 16-2817/02 Tibial Component... Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation sur... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-9041... Due to a component change, the console part of a circulatory support system may not conform to th... Class II Thoratec Switzerland GMBH
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 21, 2024 VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. ... VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biase... Class II Ortho-Clinical Diagnostics, Inc.
May 21, 2024 IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO... A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO... Class II Angiodynamics, Inc.
May 21, 2024 BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Due to a software issue the PC unit may not connect to the server which could impact wireless dat... Class II CareFusion 303, Inc.
May 20, 2024 Pink Luminous Breast, Breast transilluminator Firm is marketing and distributing the Pink Luminous Breast device without premarket approval Class II Silkprousa LLC

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.