Browse Device Recalls
2,479 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,479 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 2,479 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... | Product labeling contains incorrect expiration date | Class II | Medtronic Neurosurgery |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extension... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 27, 2023 | Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... | Thread form issue of the locking holes in that the locking screws would not properly mate with th... | Class II | Zimmer, Inc. |
| Jun 20, 2023 | Ringed DxI Reaction Vessels (RVs) | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... | Class II | Beckman Coulter, Inc. |
| May 26, 2023 | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 | There was one complaint that the sidearm of the device detached during explant of a pump. When t... | Class II | Abiomed, Inc. |
| May 24, 2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a... | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... | Class II | Stryker Medical Division of Stryker Corporation |
| May 22, 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... | Class II | Wilson-Cook Medical Inc. |
| May 22, 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... | Class II | Wilson-Cook Medical Inc. |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 16, 2023 | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... | Class II | Heartware, Inc. |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 30, 2023 | Medicine Dropper, Product Code K508 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| Mar 30, 2023 | Eye and Ear Dropper, Product Code 67082 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| 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 SUB0000594 | 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 21, 2023 | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... | Potential for the spring to become loose and fall out of the device, if the spring falls out duri... | Class II | Aesculap Implant Systems LLC |
| Mar 20, 2023 | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medi... | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. | Class II | Baxter Healthcare Corporation |
| Feb 27, 2023 | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he... | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem... | Class II | Zimmer, Inc. |
| Feb 14, 2023 | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multi... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 14, 2023 | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedur... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 18, 2022 | The Natus Cranial Access Kit is designed to be a complete, single use and dis... | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra... | Class II | Natus Medical Incorporated |
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.