Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Sep 9, 2018 Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skele... incorrect expiration date- product is listed with 02-15-2019 the correct kit expiration date is 1... Class II Vivorte, Inc.
Sep 7, 2018 V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro ... The action is being initiated because the cooling indicator board was improperly installed. This... Class II Vital Scientific N.V.
Sep 7, 2018 Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... Class II Bayer Medical Care, Inc.
Sep 7, 2018 APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... The firm identified customer sites where modules which the safety pacemaker label is missing. Inf... Class II Abbott Laboratories, Inc
Sep 7, 2018 Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usa... There is lot to lot variability for QC and patient results when using the identified reagent cart... Class II Siemens Healthcare Diagnostics, Inc.
Sep 7, 2018 Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Produ... There is lot to lot variability for QC and patient results when using the identified reagent cart... Class II Siemens Healthcare Diagnostics, Inc.
Sep 6, 2018 Altrix¿ Precision Temperature Management System Model: 8001Product Usage: T... Users may experience alarm fatigue due to frequent alarming relating to patient temperature devia... Class II Stryker Medical Division of Stryker Corporation
Sep 6, 2018 Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product ... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 6, 2018 CryoPatch SG Pulmonary Hemi-Artery, 1 graft The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product l... Class II CryoLife, Inc.
Sep 6, 2018 Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product C... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 6, 2018 Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 6, 2018 Implant Direct Scan Adapter Assembly Replant platform for the following part ... The action is being initiated due to incorrect assembly of the scan adapter . The result of the i... Class II Implant Direct Sybron Manufacturing, LLC
Sep 5, 2018 FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnos... Increased risk of false positive results for Proteus when the product is used with a specific blo... Class II BioFire Diagnostics, LLC
Sep 5, 2018 Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMa... Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of ... Class II Thoratec Switzerland GMBH
Sep 5, 2018 Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to ... Product may not meet the internal manufacturing shaft subassembly burst strength specification (F... Class II Cordis Corporation
Sep 4, 2018 Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Rese... Potential for membrane (control panel) switch errors leading to an inability of the device to cha... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Sep 4, 2018 Leica M525 F20 Surgical Microscope System The firm received complaints that the instrument tipped over when the swing arm was fully extended. Class II Leica Microsystems, Inc.
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CA... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... Class II GE Healthcare Finland Oy
Sep 4, 2018 GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARE... When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network... Class II GE Healthcare Finland Oy
Sep 4, 2018 Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological ... Product was assembled with an isolating fiberglass hose within the oven in the wrong position. Th... Class II Leica Microsystems, Inc.
Sep 4, 2018 Neuro Omega System, incorporating HaGuide software. For neurological and n... If cables are improperly connected, current may reach high charge density, causing tissue harm. Class I Alpha Omega Engineering
Sep 4, 2018 Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... Class II Philips Medical Systems (Cleveland) Inc
Sep 4, 2018 McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P P... Small hole at the end of the syringe is impeding suction of liquid. Class II Cypress Medical Products LLC
Sep 4, 2018 Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Us... There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing ... Class II CooperSurgical, Inc.
Sep 4, 2018 Colpo-Pneumo Occluder, Part CPO-6 The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. Class II CooperSurgical, Inc.
Aug 31, 2018 Solar 8000i Patient Monitoring System is used to monitor physiologic paramet... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX... The system's IFU contains a list of generators that the have been deemed compatible. Recent repo... Class II Terumo Cardiovascular Systems Corporation
Aug 31, 2018 Dash 4000 Patient Monitoring System is used to monitor physiologic parameter ... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 Dash 3000 Patient Monitoring System is used to monitor physiologic parameter ... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 Solar 8000M Patient Monitoring System is used to monitor physiologic paramet... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is ... the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and ma... Class II Accuray Incorporated
Aug 31, 2018 Solar 9500 Information Monitoring System is used to monitor physiologic para... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 Dash 5000 Patient Monitoring System is used to monitor physiologic parameter ... The patient monitors may simultaneously restart as designed if all are connected to the same netw... Class II GE Healthcare, LLC
Aug 31, 2018 Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batterie... The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) batt... Class II Widex A/S
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 BD Vacutainer Specimen Collection Cups, Cat. No. 364975 BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 Mitek Screw and Washer Depth Gauge, Product Code 219024 The device has an offset in the design that results in a reading approximately 3.2mm shorter than... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 30, 2018 KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit fo... BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The ... The product was shipped after its expiry date due to a system error. The product lidstock identi... Class II Arrow International Inc
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 The firm has identified performance anomalies with the device caused when more than 64 TD60 telem... Class II Mindray DS USA, Inc. dba Mindray North America
Aug 30, 2018 KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup... BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 BD Vacutainer Urine Collection Cups, Cat. No. 364941 BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) ... Class II Becton Dickinson & Company
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton

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.