Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Sep 18, 2024 Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusabl... Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class II Nihon Kohden America Inc
Sep 17, 2024 Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing L... The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer pack... Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 17, 2024 Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a ... When PET-CT system is executing reconstruction, if PET acquisition for another patient is perform... Class II Canon Medical System, USA, INC.
Sep 17, 2024 Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reus... Due to pin coming off of handles. Class II MicroSurgical Technology Inc
Sep 17, 2024 MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... There is discrepant labeling on the inner and outer packaging of the device. Class II Datascope Corp.
Sep 17, 2024 Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in mi... A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in ... Class II Zimmer, Inc.
Sep 17, 2024 The IMAGEnet 6 Ophthalmic Data System is a software program that is intended ... The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in th... Class II Topcon Medical Systems, Inc.
Sep 16, 2024 ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ... Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variab... Class II ImaCor Inc.
Sep 16, 2024 The Graft Tube is an optional instrument which, as designed, can be filled wi... Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used a... Class II Spineology, Inc.
Sep 16, 2024 Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 3... Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal e... Class II Ambu Inc.
Sep 16, 2024 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulm... As a result of product complaints, breathing circuits are experiencing discolored fluid which are... Class I Percussionaire Corporation
Sep 16, 2024 Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or... Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complain... Class II Cook Incorporated
Sep 13, 2024 Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for... Class II Olympus Corporation of the Americas
Sep 13, 2024 Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... There is a defect in the air-in-line software algorithm. Class I Zyno Medical LLC
Sep 13, 2024 MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... There is a potential for pinholes in the applicator pouch film which creates a sterility concern. Class II Integra LifeSciences Corp.
Sep 13, 2024 EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... Class II Olympus Corporation of the Americas
Sep 13, 2024 Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Num... Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from t... Class II Olympus Corporation of the Americas
Sep 13, 2024 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... Class III DRG International, Inc.
Sep 12, 2024 BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.... Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint f... Class II Becton Dickinson & Co.
Sep 12, 2024 iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intende... Incorrect GTIN number. Class III Iotamotion Inc
Sep 12, 2024 Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior cart... The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas sourc... Class I Baxter Healthcare Corporation
Sep 12, 2024 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Sep 12, 2024 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Sep 11, 2024 LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item N... Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer... Class II Waldemar Link GmbH & Co. KG (Corp. Hq.)
Sep 11, 2024 Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sh... Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the devi... Class II Olympus Corporation of the Americas
Sep 11, 2024 SynchroMed II Infusion Pump. Product Number: 8637-20 Potential for error and inability to interrogate pump due to data corruption in the pump memory. Class II Medtronic Neuromodulation
Sep 9, 2024 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. Class II Atrium Medical Corporation
Sep 6, 2024 Boston Scientific myLUX Patient Application for an Apple Mobile device, Mode... Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhon... Class II Boston Scientific Corporation
Sep 6, 2024 The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 Trinias unity, Digital Angiography System with Catheterization Table, Model: ... If digital angiography system is used with a specific catheterization table and the operator dire... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 Enterprise Imaging XERO Viewer- software application used for reference and d... Software defect, when an image has non-square pixel spacing, the reference/localizer line is inco... Class II Agfa Healthcare NV
Sep 6, 2024 EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor... Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, wh... Class II Enchroma Inc
Sep 5, 2024 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,... May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from e... Class II Stryker Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO I... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 NxTAG Respiratory Pathogen Panel, REF: I051C0447 Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... Class II Luminex Molecular Diagnostics Inc
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation

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.