Browse Device Recalls

1,092 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,092 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 1,092 FDA device recalls in OH.

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DateProductReasonClassFirm
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Mar 17, 2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-... Light handle covers may separate from the light handle (detach and fall off) during use, this cou... Class II Steris Corporation
Mar 7, 2023 REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Inten... Error in the Introduction section of the user manual that indicates the device may be used for th... Class II Compass Health Brands (Corporate Office)
Feb 1, 2023 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi... Kits with affected microtiter plates have the potential to produce low OD values, causing the run... Class II Quidel Corporation
Feb 1, 2023 BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein... New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein... Class II Aniara Diagnostica LLC
Jan 20, 2023 SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious... Screw connection between the turbine head and the push button may loosen and fall off during the ... Class II Coltene Whaledent Inc
Jan 3, 2023 Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)... Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher t... Class II Western/Scott Fetzer Company
Dec 15, 2022 Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d... Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that ... Class II Meridian Bioscience Inc
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Dec 12, 2022 VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte... Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... Class II Steris Corporation
Oct 17, 2022 GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ... Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri... Class II Steris Corporation
Oct 7, 2022 FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ... Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ... Class II Ferno-Washington Inc
Sep 2, 2022 Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 The scalpel holder may separate from the handle for certain lots. If the tip falls off during use... Class II Steris Corporation
Aug 10, 2022 Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... Product contains incorrect chemical indicators in packaging. Class III Steris Corporation Hopkins Facility
Jul 11, 2022 NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Par... Due to a defect identified on the EPG controller printed circuit board assembly, device performan... Class I Synapse Biomedical Inc
Jun 28, 2022 BIOPHEN UFH Control Plasma Incorrect product labeling was included in the package. Class III Aniara Diagnostica LLC
Jun 22, 2022 Revogene, Catalog no. 610210. IVD test instrument When a run is aborted, the cooling period protection does not occur and the user is able to open ... Class II Meridian Bioscience Inc
Jun 10, 2022 Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... Class III Invacare Corporation
May 31, 2022 NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... Firm has revised labeling to consistently call out storage conditions and revised the instruction... Class III Synapse Biomedical Inc
Apr 26, 2022 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... Class II Daavlin Distributing Company
Apr 26, 2022 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... Class II Daavlin Distributing Company
Apr 22, 2022 Reliance Synergy Washer/Disinfector The firm identified that when the electrical contactor component in the drying chamber of the Was... Class II Steris Corporation
Mar 30, 2022 HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 Small patient labels do not match the primary device label. The primary device label accurately i... Class II Devicor Medical Products Inc
Mar 30, 2022 Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V The battery wiring harness on affected wheelchairs may become disconnected during shipment from t... Class II Invacare Corporation
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2... Product not approved for release for US distribution Class II Steris Corporation
Mar 22, 2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2... Product not approved for release for US distribution Class II Steris Corporation
Feb 15, 2022 Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in c... The photomultiplier tube, may have compromised functionality in some instruments. As a result, th... Class II Meridian Bioscience Inc
Jan 10, 2022 Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLE... Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries,... Class II Compass Health Brands (Corporate Office)
Dec 15, 2021 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Nov 22, 2021 Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 This recall has been initiated to provide a labeling update with revised instruction how to opera... Class II Gentherm Medical, LLC
Nov 12, 2021 Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Modul... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 12, 2021 Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 12, 2021 Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Mod... Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more... Class II Invacare Corporation
Nov 3, 2021 OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... Class II Haag-Streit USA Inc
Nov 3, 2021 OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... Class II Haag-Streit USA Inc
Oct 16, 2021 Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 14, 2021 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 14, 2021 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Diagnostic ultrasound system with the specified software version and used in conjunction with a F... Class II FujiFilm Healthcare Americas Corporation
Oct 11, 2021 Affected components are limited to the Monoprice charging cable (Product # 48... Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause ... Class II Forbes Rehab Services 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.