Browse Device Recalls
3,461 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,461 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 3,461 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 2, 2018 | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 76... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antib... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-09... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 7... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immun... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody,... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Aug 2, 2018 | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 ... | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg... | Class I | Ventana Medical Systems Inc |
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 31, 2018 | ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF... | Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... | Class I | Endologix |
| Jul 30, 2018 | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, ... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Produc... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 30, 2018 | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product... | Complaints received of sporadic erroneously elevated platelet results without flags or system mes... | Class I | Beckman Coulter Inc. |
| Jul 11, 2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... | Class I | Spacelabs Healthcare, Ltd. |
| Jul 5, 2018 | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percuta... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jun 20, 2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... | Class I | Vyaire Medical |
| Jun 18, 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... | A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... | Class I | Compass Health Brands (Corporate Office) |
| Jun 12, 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... | Class I | Philips Respironics, Inc. |
| May 18, 2018 | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ... | There is a potential for a disruption in one or more of the triple layer membranes of the ventric... | Class I | BERLIN HEART GMBH |
| May 18, 2018 | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and... | Potential for control line not appearing on the test strip | Class I | Qiagen Sciences, Inc. |
| May 15, 2018 | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals... | Users have misinterpreted the display for out of range measurement indicated by the blinking" ... | Class I | Draeger Medical Systems, Inc. |
| May 15, 2018 | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals,... | Users have misinterpreted the display for out of range measurement indicated by the blinking "-... | Class I | Draeger Medical Systems, Inc. |
| May 8, 2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 8, 2018 | AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 7, 2018 | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... | When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... | Class I | Biosense Webster, Inc. |
| May 3, 2018 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... | Ingress of fluids into the device can affect various electronic circuit boards which would preven... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| May 2, 2018 | Heartware Medtronic HVAD System for cardiac use. Including the following pa... | Possible transient electrical connection interruption between an HVAD System power source (Batter... | Class I | Heartware |
| Apr 13, 2018 | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with F... | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bez... | Class I | CareFusion 303, Inc. |
| Apr 5, 2018 | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... | Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu... | Class I | Abbott |
| Mar 22, 2018 | BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UD... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 503829036... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 22, 2018 | BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 5038... | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... | Class I | Becton Dickinson & Company |
| Mar 1, 2018 | Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Feb 26, 2018 | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3... | There is a potential issue for all MindFrame Capture devices to partially detach or separate from... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 19, 2018 | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable... | Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... | Class I | Zimmer Biomet, Inc. |
| Feb 19, 2018 | SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-M... | Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... | Class I | Zimmer Biomet, Inc. |
| Jan 26, 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... | Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... | Class I | bioMerieux, 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.