Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
May 9, 2024 Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 First Source iQ Flex M. Portable cart and platform that supports an X-ray sys... Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... Class II First Source Inc
May 9, 2024 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... Class II Remote Diagnostic Technologies Ltd.
May 9, 2024 Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is par... Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccur... Class II Echonous Inc
May 8, 2024 BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit... Multitest with compromised raw material used to assess immune system status may result in flow cy... Class II Becton, Dickinson and Company, BD Biosciences
May 8, 2024 Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare en... There is a potential for the top cover of the hospital bed mattress to delaminate as a result of ... Class II Baxter Healthcare Corporation
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... Class II Integra LifeSciences Corp.
May 7, 2024 Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis ... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 ... Assays may produce false negative results due to decreased activity of the enzyme utilized in man... Class II Becton Dickinson & Co.
May 7, 2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... Class II Integra LifeSciences Corp.
May 7, 2024 CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... Class II Blue Belt Technologies, Inc
May 6, 2024 NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
May 6, 2024 American Contract Systems Spine Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Hand Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Biopsy Drape Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Special Procedure Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Cataract Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Extremity convenience kit, American Contract System... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Gyn Laparoscopy convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
May 3, 2024 ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 HA FlexTrak II-Patient transport functionality to transport the patient from ... Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... Class II Philips North America Llc
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrica... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 78210... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Sy... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 SmartPath to dStream for 3.0T Model Number (REF): 782145 The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 HA FlexTrak-Patient transport functionality to transport the patient from the... Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resu... Class II Philips North America Llc
May 3, 2024 Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electric... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc
May 3, 2024 FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical 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.