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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.