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.

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DateProductReasonClassFirm
Aug 16, 2024 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 15, 2024 STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood be... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I... Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 40... Class II Roche Diagnostics Operations, Inc.
Aug 15, 2024 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood be... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2024 ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Aug 15, 2024 Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2024 ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Aug 15, 2024 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 15, 2024 ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 1133579... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Aug 15, 2024 STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a h... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood betwe... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood... Class II B Braun Medical Inc
Aug 15, 2024 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Due to affected devices that may have bent female IUI connector and may not be operable and poten... Class II CareFusion 303, Inc.
Aug 14, 2024 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Contamination with foreign substance matter Class II 3M Company - Health Care Business
Aug 14, 2024 TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA P... Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fus... Class II Innovasis, Inc
Aug 13, 2024 Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resect... The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... Class II Olympus Corporation of the Americas
Aug 13, 2024 Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... This product labeling does not adequately provide warning about the risks associated with the use... Class II Zoe Medical Incorporated
Aug 13, 2024 Soltive Premium SuperPulsed Laser - Intended for incision, excision, resectio... The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... Class II Olympus Corporation of the Americas
Aug 13, 2024 Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... This product labeling does not adequately provide warning about the risks associated with the use... Class II Zoe Medical Incorporated
Aug 12, 2024 ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ... Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... Class II Smith & Nephew Inc.
Aug 12, 2024 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Aug 12, 2024 BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... Class II Becton, Dickinson and Company, BD Bio Sciences
Aug 12, 2024 Seer Home System is an ambulatory electroencephalograph (EEG) system intended... During CAPA investigations of sight production inconsistencies, it was highlighted that previous ... Class II SEER MEDICAL PTY LTD
Aug 12, 2024 ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio... Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... Class II Smith & Nephew Inc.
Aug 12, 2024 Custom Procedure Kit, REF: K12T-11077 7F sheath introducers labeled as 7.5F Class II Merit Medical Systems, Inc.
Aug 9, 2024 GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant war... GE HealthCare has become aware that complete electrical safety testing was not conducted during m... Class II Wipro GE Healthcare Private Ltd.
Aug 9, 2024 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL ... Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as ... Class II Physio-Control, Inc.
Aug 9, 2024 GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1... GE HealthCare has become aware that complete electrical safety testing was not conducted during m... Class II Wipro GE Healthcare Private Ltd.
Aug 9, 2024 Vios Monitoring System Bedside Monitor Model BSM2050 Batteries may deplete over time while not in use if devices are stored without being plugged in t... Class II Murata Vios, Inc.
Aug 8, 2024 ViewPoint; system, imaging processing, radiological The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... Class II GE Healthcare GmbH
Aug 8, 2024 Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i... Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... Class II Zimmer GmbH
Aug 8, 2024 Fusion Pro 24, Model 17000 a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock devic... Class II Epilog Laser Corp.
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo... Potential for product leakage from the Spin Lock Connector on the distal end of the device due to... Class II B. Braun Medical, Inc.
Aug 8, 2024 Ziehm Vision FD. Interventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) wit... Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware... Class II Fresenius Medical Care Holdings, Inc.
Aug 8, 2024 Ziehm Vision R. Iterventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision system, x-ray, tomography, computed. Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals ... Class III T.G. Eakin Limited
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.

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.