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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 12, 2020 | Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c... | Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) | Class I | Medtronic Vascular Galway DBA Medtronic Ireland |
| May 6, 2020 | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A... | A material weakness adjacent to the polymer fill channel may become compromised during pressuriza... | Class I | Endologix, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
| Mar 24, 2020 | CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L ... | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. ... | Class I | Smiths Medical ASD Inc. |
| Mar 23, 2020 | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e165... | There has been an increased trend in reports of catheters failing to deflate during use, which ma... | Class I | LeMaitre Vascular, Inc. |
| Mar 16, 2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | Class I | Vascular Solutions, Inc. |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device. For neurological endovascular use. | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 14, 2020 | ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For ... | Embolization device delivery system may fracture at the distal section during device implantation... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 11, 2020 | Imager II 5F Angiographic Catheters, 5 units per package. | Potential for tip detachment of Imager II 5F Angiographic Catheters | Class I | Boston Scientific Corporation |
| Feb 4, 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 108854038... | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris PCA Module, Model 8120 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris Pump Module, Model 8100 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Feb 4, 2020 | CareFusion Alaris Syringe Module, Model 8110 | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result i... | Class I | CareFusion 303, Inc. |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 29, 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Abbott Vascular |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 23, 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... | Class I | Heartware, Inc. |
| Jan 7, 2020 | CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG ... | Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster ... | Class I | CME America, LLC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, RE... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 13, 2019 | HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperatu... | There is the potential for water to flood the column and enter the circuit under circumstances wh... | Class I | TELEFLEX MEDICAL INC |
| Dec 12, 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Combination of software and a component failure may cause audible alarms not to operate properly,... | Class I | ResMed Ltd. |
| Dec 4, 2019 | 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114... | The stiffness of the soft end of the guidewire caused tissue perforation. | Class I | Argon Medical Devices, Inc |
| Dec 4, 2019 | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141... | The stiffness of the soft end of the guidewire caused tissue perforation. | Class I | Argon Medical Devices, Inc |
| Nov 25, 2019 | Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended... | GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... | Class I | GE Healthcare, LLC |
| Nov 25, 2019 | Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended... | GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... | Class I | GE Healthcare, LLC |
| Nov 21, 2019 | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic 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.