Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Nov 14, 2023 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ... CARDIOHELP-i System was not properly tested to measure leakage current Class III Maquet Medical Systems USA
Nov 14, 2023 BD Recanalization System, REF: BDRECANSYSTEM Recanalization systems may be in a manufacturing mode that allows the system to continuously run ... Class II Bard Peripheral Vascular Inc
Nov 13, 2023 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level... There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum ... Class II Randox Laboratories Ltd.
Nov 13, 2023 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... Identification label on affected hookups could become illegible over time due to the label's ink ... Class II Steris Corporation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-40, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-20, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Venous probe connection cable (REF 701069333 and 701048804) used with the Car... Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe con... Class II Maquet Medical Systems USA
Nov 13, 2023 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Possibility that the user is unable to resolve drill disconnection error messages. Class II Blue Belt Technologies, Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex LOGICAL CATH LAB KIT, List Number M20754 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 6IN PRESSURE TUBING, List Number MX20617 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilati... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation o... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP
Nov 10, 2023 EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of ... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of stric... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of ... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of str... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 8, 2023 Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Missi... The internal diameter of the coaxial cannula may be smaller or larger than the external diameter ... Class II Bard Peripheral Vascular Inc
Nov 8, 2023 Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - A... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and P... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AX... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E -... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light S... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF ... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Ca... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numb... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 8, 2023 Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Cata... A potential for a light system to fall in the operating room. Class II Getinge Usa Sales Inc
Nov 7, 2023 Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... Class II Abiomed, Inc.
Nov 7, 2023 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul... Potentially defective utility trays in the reagent kits. Class II Luminex Corporation

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.