Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Cat... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 22, 2025 | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100... | Due to incorrect software configuration that potentially allows more than two (2) fractions withi... | Class II | Reflexion Medical, Inc. |
| Jul 21, 2025 | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode... | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | Class II | B.Braun Medical S.A.S. |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The ST... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 19, 2025 | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit M... | Device contains indications for use and device compatibility claims that have not be reviewed and... | Class II | Insightra Medical Inc |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 17, 2025 | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculati... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 17, 2025 | Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant ... | Measles IgM Test Kit lacks premarket approval or clearance. | Class II | Quest International, Inc. |
| Jul 14, 2025 | 3mensio Workstation (Vascular Fenestrated) software | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i... | Class II | PIE Medical Imaging B.V. |
| Jul 14, 2025 | Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001... | Under certain conditions, such as the simultaneous use of the operating table with other medical ... | Class II | MAQUET GMBH |
| Jul 10, 2025 | Multi Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-MULTI-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | All-round Joystick R-net Light. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-ARLITE-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | Micro Joystick R-net. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 10, 2025 | IDM-MICRO-R. Electrical wheelchair component. | Devices with firmware versions 2.3 and lower may experience timing variations between software ta... | Class I | mo-Vis BVBA |
| Jul 8, 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jun 30, 2025 | Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD... | Potential for temporary loss of imaging (X-ray) functionality due to software issue. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | SPINEART SA |
| Jun 30, 2025 | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SC... | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | SPINEART SA |
| Jun 26, 2025 | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation ... | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas ... | Class II | bioMerieux, Inc. |
| Jun 25, 2025 | Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrumen... | Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SA... | Class II | Nuclein LLC |
| Jun 25, 2025 | UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 25, 2025 | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries... | Class II | Beckman Coulter, Inc. |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 23, 2025 | BD COR System Software. Model Number: 444829. | Potential for functionality issue that supports the Over labeling feature and could lead to poss... | Class II | Becton Dickinson & Co. |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 20, 2025 | Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... | Unintended radial detector motion may occur during patient setup or during patient scan if system... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Jun 20, 2025 | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... | Unintended radial detector motion may occur during patient setup or during patient scan if system... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 20, 2025 | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX | Certain Spectrum infusion pumps may have an incorrect version of software. | Class I | Baxter Healthcare Corporation |
| Jun 18, 2025 | Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/C... | There is the potential that the silicone implant may contain foreign material | Class II | Osteotec Limited |
| Jun 18, 2025 | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 16, 2025 | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e... | Class II | Medtronic MiniMed, Inc. |
| Jun 12, 2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... | Class II | Encore Medical, LP |
| Jun 12, 2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... | Class II | Encore Medical, LP |
| Jun 11, 2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... | Devices had an unapproved slabbing software function enabled for use. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
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.