Browse Device Recalls

94 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 94 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 94 FDA device recalls.

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DateProductReasonClassFirm
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
Oct 4, 2023 Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Sep 7, 2023 Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Inadvertent release of embolectomy catheters that may experience slower than normal balloon defla... Class II Edwards Lifesciences, LLC
Jul 27, 2023 PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mi... Class II Edwards Lifesciences, LLC
Feb 14, 2023 Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermo... There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... Class II Edwards Lifesciences, LLC
Feb 14, 2023 Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Therm... There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... Class II Edwards Lifesciences, LLC
Oct 6, 2022 Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... Class II Edwards Lifesciences, LLC
Oct 6, 2022 Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 12... Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... Class II Edwards Lifesciences, LLC
Mar 1, 2022 FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10 The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... Class II Edwards Lifesciences, LLC
Mar 1, 2022 FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monito... The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter M... Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Num... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F ... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
Jul 9, 2021 Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F... There is a potential for internal leaks within catheters. Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Mon... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure M... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx On... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Steril... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
May 26, 2021 Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure ... There is a potential that the pressure tubing may detach from the blood sampling system Class II Edwards Lifesciences, LLC
Mar 27, 2020 Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFK... Sterile catheter kit packaging compromised. Class II Edwards Lifesciences, LLC
Nov 27, 2019 QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:... If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e... Class II Edwards Lifesciences, LLC
Oct 22, 2019 EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vente... Their is a possibility that the cannula may separate from its connector, potentially causing a br... Class II Edwards Lifesciences, LLC
Oct 7, 2019 Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usag... Intermittent communication due to inconsistent crimping of connectors onto cables. Class II Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
May 14, 2019 IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.... Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during c... Class I Edwards Lifesciences, LLC
Mar 28, 2019 Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 28, 2019 Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... Class I Edwards Lifesciences, LLC
Mar 21, 2019 EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usag... Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress i... Class I Edwards Lifesciences, LLC
Jan 22, 2019 Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Num... This action has been initiated to address complaint reports received for crimp balloon and inflat... Class II Edwards Lifesciences, LLC
Jan 16, 2019 Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a... Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen l... Class II Edwards Lifesciences, LLC
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Produc... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, 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.