Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
Jul 18, 2023 Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 18, 2023 Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... Class I Abbott Medical
Jul 12, 2023 Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed t... Class I Draeger Medical, Inc.
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, 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 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, 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, 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, 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, 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 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 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, 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, 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 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 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, 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, 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 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, 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 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, 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 15, 2023 The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35... A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... Class I Baxter Healthcare Corporation
Jun 15, 2023 HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressur... Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ... Class I Hamilton Medical, Inc.
Jun 15, 2023 SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... Class I Baxter Healthcare Corporation
Jun 15, 2023 HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended t... Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ... Class I Hamilton Medical, Inc.
Jun 15, 2023 HAMILTON C2 Ventilator Is intended to provide positive pressure ventilator... Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ... Class I Hamilton Medical, Inc.
Jun 15, 2023 HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positi... Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop ... Class I Hamilton Medical, 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 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 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 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 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 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 12, 2023 Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a per... There is an overall reported incidence rate of 0.77% related to observed or potential air embolis... Class I Abbott
Jun 12, 2023 Oxylog 3000 Plus emergency and transport ventilator Draeger has become aware of instances where the device stopped working when in use when transitio... Class I Draeger Medical, Inc.
Jun 8, 2023 Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q1... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas

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.