Browse Device Recalls
3,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,428 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 3,428 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2023 | VentStar Watertrap (P) 180, MP00361 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 11, 2023 | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... | Class I | Medtronic Navigation, Inc. |
| Apr 11, 2023 | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... | Class I | Medtronic Navigation, Inc. |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... | There were reports from customers that the tracheostomy in the sets and trays is not making a sec... | Class I | Cook Incorporated |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... | There were reports from customers that the tracheostomy in the sets and trays is not making a sec... | Class I | Cook Incorporated |
| Mar 31, 2023 | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... | The liquid buffer component in the affected test kit lots was determined to have bacterial contam... | Class I | SD Biosensor, Inc. |
| Mar 28, 2023 | Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control dri... | Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result... | Class I | Percussionaire Corporation |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM | 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 501814RE | 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 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 701814RE | 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 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 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 603014MC | 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 801814RMC | 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 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... | Class I | Cordis US Corp |
| Mar 24, 2023 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: ... | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy ... | Class I | Covidien |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC | 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 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 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 | 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 SUB0000864 | 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: 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 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: 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 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 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 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 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 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 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 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 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 , 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 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 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. |
| 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. |
| 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 | 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 |
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.