Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 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 774 FDA device recalls.

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DateProductReasonClassFirm
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 18, 2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladde... Class II C.R. Bard Inc
May 29, 2025 SmartPath to dStream for 1.5T¿; Product Number: 782146; identified an issue where a component failure in the specific Gradient Coil type of affected syst... Class II Philips North America
May 13, 2025 Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
May 13, 2025 Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 Potential for alignment errors in the cross reference line functionality when reviewing images ge... Class II Philips North America Llc
Apr 22, 2025 Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 ro... Firm has received an increase in reports regarding inadvertent instrument lockout during surgical... Class I Ethicon Endo-Surgery Inc
Mar 24, 2025 SmartPath to dStream for 1.5T, Model Number: 782146; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 24, 2025 SmartPath to dStream for 3.0T, Model Number: 782145; The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 20, 2025 The Alinity m System is designed to automate the steps for nucleic acid testi... The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... Class II Abbott Molecular, Inc.
Feb 12, 2025 namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical con... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG;... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 8064172... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, R... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 5, 2025 MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (... Entering multiple keys that trigger input simultaneously may remove data from first field of scre... Class II Medical Information Technology, Inc.
Jan 2, 2025 Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK ... Due to devices being irradiated above the established specification which my result in package in... Class II US Endodontics, LLC
Dec 20, 2024 PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Sutur... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
Dec 20, 2024 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so... Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... Class II Ethicon, LLC
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

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.