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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Date	Product	Reason	Class	Firm
Sep 27, 2023	StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste...	Due to a software anomaly which potentially could result in the surgical planning data shifting t...	Class I	Medtronic Navigation, Inc.
Sep 26, 2023	Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,...	Non-sterile product labeled as sterile was distributed.	Class I	Cordis US Corp
Sep 22, 2023	Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.	There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur...	Class I	Olympus Corporation of the Americas
Sep 21, 2023	8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System	Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In...	Class I	B. Braun Medical, Inc.
Sep 21, 2023	8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ...	Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In...	Class I	B. Braun Medical, Inc.
Sep 20, 2023	Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 20, 2023	Monoject 20 mL Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 20, 2023	Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 20, 2023	Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 20, 2023	Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 20, 2023	Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack	Demonstrated recognition and compatibility issues with syringe infusion pumps.	Class I	Cardinal Health 200, LLC
Sep 15, 2023	Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ...	Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur...	Class I	Asensus Surgical Inc
Sep 15, 2023	BD Alaris PCU REF 8015	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
Sep 15, 2023	BD Alaris Syringe Module, REF 8110	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
Sep 15, 2023	Alaris PCA Module 8120	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
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 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 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 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. CDX BLUESTAR	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 Hemodialysis System w/Bibag	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, 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 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 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 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 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	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	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 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 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 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 reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card...	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 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 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-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-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 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: 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, 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	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

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.