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Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
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, 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, 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, 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, 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, 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, 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, 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 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 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, 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, 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 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 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 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 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 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 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 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 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 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 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 BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60... 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 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 BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 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
Jun 8, 2023 Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 6, 2023 GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator a... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 6, 2023 GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, 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.