Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2026 | Burlington Medical, Demi Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Vest | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Leg Wraps. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Wrap Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 11, 2026 | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 11, 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... | Class II | CareFusion 303, Inc. |
| Feb 10, 2026 | Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAG... | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory respo... | Class II | Medline Industries, LP |
| Feb 10, 2026 | Artegraft Vascular Graft; REF#: AG740; | Labeling mix-up resulting in the incorrect lot outer packaging of product. | Class II | LeMaitre Vascular, Inc. |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 componen... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
| Feb 10, 2026 | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... | Class II | Boston Scientific Corporation |
| Feb 9, 2026 | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... | Class II | Reflexion Medical, Inc. |
| Feb 9, 2026 | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Feb 6, 2026 | BD Kiestra" ReadA; Catalog No.: 446948. | In certain situations, following a system reboot, one or more modules may have become unreachable... | Class II | BD KIESTRA LAB AUTOMATION |
| Feb 6, 2026 | Battery Charging Station; Model: 0998-00-0802; | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP ... | Class III | Datascope Corp. |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Artelon FlexBand Plus Ref: 41054 & 41057 | Augmentation devices failed bacterial endotoxin testing. | Class II | International Life Sciences |
| Feb 6, 2026 | Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) ... | Augmentation devices failed bacterial endotoxin testing. | Class II | International Life Sciences |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Artelon FlexBand Dynamic Matrix Ref: 31057 | Augmentation devices failed bacterial endotoxin testing. | Class II | International Life Sciences |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 5, 2026 | Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog N... | After receiving customer complaints, investigations confirmed the presence of a positive bias in ... | Class II | Diagnostica Stago, Inc. |
| Feb 5, 2026 | Campy CVA Medium 100/PK, R01272 | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lo... | Class II | Remel, Inc |
| Feb 4, 2026 | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number... | Potential for the Cassette Loading Lever to break. | Class II | Fresenius Kabi USA, LLC |
| Feb 4, 2026 | React Health PHOENIX 5L Oxygen Concentrator | Devices which did not meet internal quality specifications were inadvertently distributed. | Class II | 3B Medical, Inc. |
| Feb 4, 2026 | Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei... | The potential of out-of-range results and an underestimation of the free protein S level in norma... | Class II | Diagnostica Stago, Inc. |
| Feb 3, 2026 | Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (... | There is a potential issue that can lead to discordance between the simulated needle trajectory/t... | Class II | GE Medical Systems, LLC |
| Feb 3, 2026 | IBA Proton Therapy System - PROTEUS 235 | It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S... | Class II | Ion Beam Applications S.A. |
| Feb 3, 2026 | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Cata... | Impactor handle may be missing cross-pin | Class II | Exactech, Inc. |
| Feb 3, 2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/... | Impactor handle may be missing cross-pin | Class II | Exactech, Inc. |
| Feb 2, 2026 | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | A potential issue was identified with the torque strength on the external screws of the MICS3 Ang... | Class II | Howmedica Osteonics Corp. |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 1, 2026 | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | Heart valves were released and distributed before all required testing was complete, so it cannot... | Class II | On-X Life Technologies, Inc. |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Tandem pumps are battery-operated infusion pumps capable of both basal and bo... | The Czech language user guide contained multiple translation errors. The most significant error ... | Class II | Tandem Diabetes Care, Inc. |
| Jan 30, 2026 | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... | Class II | Medtronic MiniMed, Inc. |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... | Due to complaints and investigations stating that alarms from the primary patient bedside monitor... | Class II | Covidien LLC |
| Jan 30, 2026 | DxC 700 AU, REF: B86444, B86446 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 30, 2026 | Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) ... | The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and acce... | Class II | Medline Industries, LP |
| Jan 30, 2026 | CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TR... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical 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.