Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
May 31, 2024 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has b... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external def... G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the scr... Class II Zoll Medical Corporation
May 31, 2024 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 31, 2024 Soltive Pro SuperPulsed Laser System, Model TFL-SLS Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 30, 2024 Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part numb... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
May 30, 2024 Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is ... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiac Catheterization 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 Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... 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 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: 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 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 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 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 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 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 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 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 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-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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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.