Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Dec 2, 2020 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of ant... Due to a customer report and internal investigation, it was confirmed that a portion of the affec... Class II Beckman Coulter Inc.
Nov 18, 2020 Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspe... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 18, 2020 MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intend... The firm has identified a problem with the control software for the celling arm of the X-Ray Syst... Class II Shimadzu Medical Systems
Nov 12, 2020 CareLink Personal Software Therapy Management Software Tool for Diabetes Car... Incomplete basal rate information may be transmitted leading to a potential for inappropriate cha... Class II Medtronic Inc.
Nov 11, 2020 Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A A software problem has been identified which could result in the diagnostic imaging system not p... Class II Canon Medical System, USA, INC.
Nov 9, 2020 Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product... A software problem has been identified which could result in the CT Scanner not proceeding to th... Class II Canon Medical System, USA, INC.
Nov 9, 2020 icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... Due to a potential software issue, the display may show the incorrect continuous cardiac output (... Class II ICU Medical, Inc.
Nov 9, 2020 Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjust... There is a potential that the adjustable handle option on the X-Ray system may have been installe... Class II Shimadzu Medical Systems
Nov 3, 2020 Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed o... It has been determined that the software distributed with the retinal camera may delete patient i... Class II Kowa Optimed Inc
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Nov 2, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 30, 2020 Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... Class II Respironics California, LLC
Oct 23, 2020 Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, ... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 VGlove NITRILE *** Protect Your Life 100 Patient examination gloves Package labeled as nitrile gloves, contains latex gloves. Class II HUBO INTERNATIONAL INC
Oct 23, 2020 Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division
Oct 23, 2020 Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tub... There is a potential for contamination within Viral Transport Media. Use of contaminated Viral T... Class II Hardy Diagnostics
Oct 23, 2020 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag... The distal tip ring of the fully articulating catheter may become dislodged during the procedure. Class II Intuitive Surgical, Inc.
Oct 23, 2020 Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-... Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant ball... Class II Medtronic Heart Valves Division

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.