Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 17, 2024 | Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... | Class II | Maquet Cardiovascular, LLC |
| May 17, 2024 | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hi... | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to jo... | Class II | Biomet, Inc. |
| May 17, 2024 | Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| May 17, 2024 | Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| May 17, 2024 | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Ma... | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3.... | Class II | Siemens Healthcare Diagnostics Inc |
| May 17, 2024 | The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead ... | Class II | Maquet Cardiovascular, LLC |
| May 17, 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | Electroneurodiagnostic medical device may contain a defective printed circuit board which may ca... | Class II | Cadwell Industries Inc |
| May 16, 2024 | Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only | The duration between the implantable pulse generator reaching the elective replacement indicator... | Class II | Abbott Medical |
| 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 16, 2024 | Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: ... | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 16, 2024 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point ran... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 16, 2024 | Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only | The duration between the implantable pulse generator reaching the elective replacement indicator... | Class II | Abbott Medical |
| May 16, 2024 | Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only | The duration between the implantable pulse generator reaching the elective replacement indicator... | Class II | Abbott Medical |
| May 16, 2024 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit... | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport m... | Class II | BioFire Diagnostics, LLC |
| May 16, 2024 | Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only | The duration between the implantable pulse generator reaching the elective replacement indicator... | Class II | Abbott Medical |
| May 16, 2024 | Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... | The duration between the implantable pulse generator reaching the elective replacement indicator... | Class II | Abbott Medical |
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.