Browse Device Recalls

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 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 806 FDA device recalls.

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DateProductReasonClassFirm
Dec 20, 2024 PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Nov 6, 2024 BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicil... BD identified through potency testing as part of a stability test request to monitor Ampicillin A... Class II Becton Dickinson & Co.
Sep 25, 2024 intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... Class II Biocare Medical, LLC
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
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 + 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 + 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 + 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 +SARS-CoV-2, REF: I056C0468 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 3, 2024 SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Aug 29, 2024 Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrum... Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobact... Class II Microcare Medical
Aug 20, 2024 Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 19, 2024 IntelliSystem Inflation Device, REF: IN1525/D Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 StabiliT TOUCH Syringe, REF: IN8VCF/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8140/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 BlueFIRE Inflation Device, REF: IN10140 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixSKY Inflation Device, REF: SKY1802 Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... Class II Merit Medical Systems, Inc.
Jul 25, 2024 Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... Class I Breas Medical, Inc.
Jun 24, 2024 Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... Any single affected ventilator should only be used for the 10- year labelled service life, but if... Class I Covidien
May 13, 2024 Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... Class II Roche Diabetes Care, Inc.
May 3, 2024 SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... 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 SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Med... The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... Class II Philips North America Llc

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.