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
Sep 13, 2023 Astral 100 and Astral 150 ventilators If ventilator is on internal battery, not intended to serve as a primary power source, low/critic... Class I ResMed Ltd.
Sep 11, 2023 Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural... Infusion Pumps with affected software revision may fail to detect air in line, which may lead to ... Class I EITAN MEDICAL LTD
Sep 6, 2023 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T Hemodialysis System w/Bibag Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T GEN 2 Bibag without CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T HD SYS. CDX W/BIBAG BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T Hemodialysis System without CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T HD SYS. W/O CDX BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T HD SYS. CDX BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 2008T Hemodialysis SYS, with CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Aug 25, 2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... Class I Philips Respironics, Inc.
Aug 10, 2023 Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pr... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
Aug 10, 2023 Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC p... This recall has been initiated due to reports that the product code and product name were incorre... Class I ARROW INTERNATIONAL Inc.
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 8, 2023 Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #... The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. Class I Mallinckrodt Manufacturing LLC
Aug 4, 2023 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 26, 2023 Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-MR1, REF: 161010, Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
Jul 26, 2023 Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte ont... Class I Hamilton Medical, Inc.
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" 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 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 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 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 Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... 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, 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, 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, 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

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.