Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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, 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 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, 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 | 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 | 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 | 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 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 16, 2023 | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | 30mm screws were labeled as 25mm screws. | Class II | Conformis, Inc. |
| Jun 14, 2023 | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Nu... | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella CP with SmartAssist intravascular micro axial blood pump, Product Num... | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella 5.0 intravascular micro axial blood pump, Product Number 005062 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella LD intravascular micro axial blood pump, Product Number 005082 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01... | Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco... | Class II | Philips North America Llc |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 6, 2023 | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... | 1. Wheels loosening over time with use of the device could lead to the inability to effectively d... | Class II | NeuroLogica Corporation |
| Jun 1, 2023 | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 1, 2023 | epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 1, 2023 | epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... | There is potential for discrepant high glucose results in samples with glucose results on the low... | Class II | Siemens Healthcare Diagnostics 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 25, 2023 | Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device th... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device tha... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a d... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
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.