Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 22, 2023 Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000864 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000594 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 10, 2023 Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resu... Class I Fresenius Kabi USA, LLC
Mar 1, 2023 Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 10, 2023 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... A limited number of remediated Philips DreamStation units may experience communication issues whe... Class I Philips Respironics, Inc.
Feb 7, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile... Class I Datascope Corp.
Feb 7, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord c... An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coile... Class I Datascope Corp.
Feb 7, 2023 Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-08... An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P... Class I Datascope Corp.
Feb 7, 2023 Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-080... An unexpected shutdown of the IABP may occur due to loss of communication between the Executive P... Class I Datascope Corp.
Feb 3, 2023 BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. Potential for product manifold to crack during use on patients, possibly causing leaks in the res... Class I Avanos Medical, Inc.
Feb 3, 2023 BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. Potential for product manifold to crack during use on patients, possibly causing leaks in the res... Class I Avanos Medical, Inc.
Jan 25, 2023 Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilator... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventil... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventila... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of ind... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 23, 2023 NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0... The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... Class I Draeger Medical, Inc.
Jan 23, 2023 NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S)... The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... Class I Draeger Medical, Inc.
Dec 22, 2022 Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ... Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 22, 2022 Getinge Flow-e Anesthesia System, Part No. 6887900 Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 22, 2022 Getinge Flow-c Anesthesia System, Part No. 6887700 Due to a software bug, under certain conditions, pressure cannot be built up resulting in no vent... Class I Getinge Usa Sales Inc
Dec 19, 2022 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... Class I Datascope Corp.
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 /... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ G... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-080... The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when ... Class I Datascope Corp.
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 D... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / D... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 9, 2022 CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24... There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... Class I Smiths Medical ASD Inc.
Dec 9, 2022 CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... Class I Smiths Medical ASD Inc.
Dec 9, 2022 CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... Class I Smiths Medical ASD Inc.
Dec 9, 2022 CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... Class I Smiths Medical ASD Inc.
Dec 9, 2022 CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24... There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... Class I Smiths Medical ASD Inc.
Dec 7, 2022 Philips Garbin Ventilator, Model Number 1058180B The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... Class I Philips Respironics, Inc.
Dec 7, 2022 Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... Class I Philips Respironics, Inc.
Dec 7, 2022 Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... Class I Philips Respironics, Inc.

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.