Browse Device Recalls

3,378 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,378 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 3,378 FDA device recalls in MA.

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DateProductReasonClassFirm
Aug 8, 2023 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 b... There is a potential for blood backfill leakage and foreign material. Class I Fresenius Medical Care Holdings, Inc.
Aug 8, 2023 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes... There is a potential for blood backfill leakage and foreign material. Class I Fresenius Medical Care Holdings, Inc.
Aug 8, 2023 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... There is a potential for blood backfill leakage and foreign material. Class I Fresenius Medical Care Holdings, Inc.
Aug 2, 2023 Incisive CT, software version 5.0 Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... Class II Philips Healthcare
Jul 25, 2023 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... Ground cable installed incorrectly. Class II Medtronic Navigation, Inc.-Littleton
Jul 13, 2023 The Chevalier Valvulotome is a device used to disrupt the valves of veins whi... Burrs (molding flash) on the cutter may tear the harvested vien Class II LeMaitre Vascular, Inc.
Jul 13, 2023 ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use... Sample misidentification could occur under specific conditions and patient management altered b... Class II Instrumentation Laboratory
Jun 29, 2023 Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product ... A higher than expected rate of thrombus formation or deposition has been observed. The risk is f... Class I Abiomed, Inc.
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, 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, 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

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.