Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | Alcon Custom Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Phaco Standalone Tips | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 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, 16 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, 16 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, 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 | ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| 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 | Infinity FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| 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 | Constellation Procedure Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| 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 | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... | There is potential the device inside the package may not match the product information on the out... | Class II | Stryker Corporation |
| 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 | stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... | There is potential the device inside the package may not match the product information on the out... | Class II | Stryker Corporation |
| 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 | Legion FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| 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 | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... | There is potential the device inside the package may not match the product information on the out... | Class II | Stryker Corporation |
| Jun 28, 2023 | Centurion FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| 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 26, 2023 | Fargo Ortho-K Lens | Manufactured lenses are not covered by existing FDA approval | Class II | PARAGON VISION SCIENCES, Inc |
| Jun 26, 2023 | ISee Ortho-K Lens | Manufactured lenses are not covered by existing FDA approval | Class II | PARAGON VISION SCIENCES, Inc |
| Jun 26, 2023 | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software | Software issue | Class II | Digisonics, Inc |
| Jun 23, 2023 | Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... | Certain lots of the products have a Naphthalene odor. | Class II | Microtek Medical Inc. |
| Jun 23, 2023 | SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used ... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, use... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | ellacor System with Micro-Coring Technology-Indicated for use by medical prof... | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y ... | Class II | Cytrellis Biosystems, Inc. |
| Jun 23, 2023 | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... | There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... | Class II | Scholly Fiberoptic Gmbh |
| Jun 23, 2023 | YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provid... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... | Certain lots of the products have a Naphthalene odor. | Class II | Microtek Medical Inc. |
| Jun 23, 2023 | SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to p... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
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.