Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
Mar 3, 2022 iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 ... Firm has observed increased rate of customer complaints related to separation of the balloon or c... Class I Atrium Medical Corporation
Mar 3, 2022 Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Numb... Firm has observed increased rate of customer complaints related to separation of the balloon or c... Class I Atrium Medical Corporation
Mar 2, 2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... There is potential for the capsule bond to break during the procedure. Class I Medtronic Inc
Feb 28, 2022 Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Feb 28, 2022 Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Feb 28, 2022 Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... Class I Respironics California, LLC
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Jan 31, 2022 STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... Class I SD Biosensor, Inc.
Jan 27, 2022 E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purp... Class I E25Bio, Inc.
Jan 24, 2022 Philips Respironics V60 Plus Ventilator Part Number 1138747 A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... Class I Respironics California, LLC
Jan 24, 2022 Philips Respironics V60 Ventilator Part Number 1053617 A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... Class I Respironics California, LLC
Jan 13, 2022 Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Jan 13, 2022 COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Jan 13, 2022 LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF ... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (fin... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 11, 2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containi... The firm received reports indicating PTD tip separation during use. Class I TELEFLEX MEDICAL INC
Jan 10, 2022 RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component... The product does not have 510(k) clearance. Class I BASE 10 GENETICS INC
Dec 29, 2021 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 29, 2021 Baxter Spectrum IQ Infusion Pumps, Product code 3570009. There is the potential for reduced or non-delivery of medication, in some cases without alerting ... Class I Baxter Healthcare Corporation
Dec 28, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 The affected lot was placed under quarantine in September 2021 due to complaints of alleged false... Class I CELLTRION USA INC
Dec 22, 2021 CovClear COVID-19 Rapid Antigen Test, ATG 900-031 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 COVID test kits were offered for sale and distributed to consumers in the United States without m... Class I Empowered Diagnostics LLC
Dec 22, 2021 Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Dec 22, 2021 Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, Inc.
Dec 20, 2021 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... Potential cessation in ventilation can occur under specific conditions. Class I Vyaire Medical
Dec 14, 2021 OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ... The firm has received complaints of the OXY-1 System Console experiencing a power interruption wh... Class I Abiomed, Inc.
Dec 9, 2021 Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo... A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) h... Class I Getinge Usa Sales Inc
Dec 6, 2021 Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1... Reports have been received of tip damage during use of the devices which resulted in some instanc... Class I ev3 Inc.
Dec 6, 2021 Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1... Reports have been received of tip damage during use of the devices which resulted in some instanc... Class I ev3 Inc.
Dec 2, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Returned test kits were erroneously shipped to customers. The kits are intended for Research Use ... Class I CELLTRION USA INC
Nov 22, 2021 WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s... Class I Cardiovascular Systems Inc
Nov 15, 2021 Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Nov 15, 2021 Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Nov 11, 2021 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... Class I Medtronic Navigation, Inc.
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980S1ENDICU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator,980X1ENAIQC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w... Class I Covidien Llc

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.