Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

Date	Product	Reason	Class	Firm
Dec 19, 2023	iQ Waste Well Adapter, Part Number: 700-3393	Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear...	Class II	Beckman Coulter, Inc.
Dec 19, 2023	Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ...	Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ...	Class II	OriGen Biomedical, Inc.
Dec 19, 2023	Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716	Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part...	Class II	Smiths Medical ASD Inc.
Dec 19, 2023	iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 7...	Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear...	Class II	Beckman Coulter, Inc.
Dec 19, 2023	smiths medical Medfusion Model 4000 syringe pump	Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f...	Class I	Smiths Medical ASD Inc.
Dec 19, 2023	Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C7...	Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear...	Class II	Beckman Coulter, Inc.
Dec 19, 2023	Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-01...	Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part...	Class II	Smiths Medical ASD Inc.
Dec 19, 2023	smiths medical Medfusion Model 3500 Syringe pump	Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. D...	Class I	Smiths Medical ASD Inc.
Dec 18, 2023	regard Operative LAP, Item Number 800943001; surgical convenience kit	Surgical convenience kits were manufactured with a component which was subsequently recalled by N...	Class I	ROi CPS LLC
Dec 18, 2023	Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25	Reason for the voluntary recall is residue was identified on the two forceps tips of a customer i...	Class II	Vortex Surgical Inc.
Dec 18, 2023	TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F ...	When the catheters are used with the EnSiteX EP System, the system does not correctly recognize t...	Class II	St. Jude Medical, Atrial Fibrillation Division,...
Dec 18, 2023	PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78...	Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak du...	Class II	Angiodynamics, Inc.
Dec 15, 2023	Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry	Potential for a negative bias with quality control (QC) and patient sample results when using the...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 15, 2023	ESG PK CUTTING FORCEPS, 5MM, 33CM	The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or duri...	Class II	Olympus Corporation of the Americas
Dec 15, 2023	BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478...	Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce...	Class I	Philips North America
Dec 15, 2023	PANTHER FUSION System REF 9121010000 The Panther System is an integrated...	Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.	Class II	Hologic, Inc.
Dec 15, 2023	BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 8824...	Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce...	Class I	Philips North America
Dec 15, 2023	ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/...	Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s ra...	Class II	Philips North America
Dec 15, 2023	ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy...	Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients rad...	Class II	Philips North America
Dec 15, 2023	BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12...	Detector may unexpectedly fall due to a component failure. If the detector is positioned below ce...	Class I	Philips North America
Dec 15, 2023	ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model...	Devices may not be rendered sterile due to an internal gap that may be present on some devices ca...	Class II	Globus Medical, Inc.
Dec 14, 2023	FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only...	Their is a potential for false positive results when using Pneumonia panel.	Class II	BioFire Diagnostics, LLC
Dec 14, 2023	FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IV...	Their is a potential for false positive results when using Pneumonia panel.	Class II	BioFire Diagnostics, LLC
Dec 13, 2023	Spectral CT on Rails: Software Version 5.1.0.X, model 728334.	A software issue that can incorrectly label all captured images that may lead to misdiagnosis and...	Class II	PHILIPS MEDICAL SYSTEMS
Dec 13, 2023	Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th...	Class I	Maquet Cardiovascular, LLC
Dec 13, 2023	DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620	DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 13...	Class II	Diasorin Inc.
Dec 13, 2023	Sedecal X Optima URS digital mobile diagnostic x-ray system. A a station...	Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.	Class II	SEDECAL SA
Dec 13, 2023	Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit	Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th...	Class I	Maquet Cardiovascular, LLC
Dec 13, 2023	Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi...	A software issue that can incorrectly label all captured images that may lead to misdiagnosis and...	Class II	PHILIPS MEDICAL SYSTEMS
Dec 12, 2023	TECNIS Toric II OptiBlue IOL Models ZCW	Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks ...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 12, 2023	Dual Articulating Headrest, Velcro P/N P141210813, REF BF753	Dual-articulating head rest may not stay in place or may fail to lock into position during a pati...	Class II	Steris Corporation
Dec 12, 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Dual-articulating head rest may not stay in place or may fail to lock into position during a pati...	Class II	Steris Corporation
Dec 12, 2023	VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 ...	Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clott...	Class II	Greiner Bio-One North America, Inc.
Dec 12, 2023	High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx On...	Due to an assembly error within the breathing circuit, their pressure output of the breathing cir...	Class I	Percussionaire Corporation
Dec 12, 2023	Philips Azurion system, Interventional fluoroscopic x-ray system. System P...	System may exhibit a loss of imaging functionality and data due to an issue which can cause the s...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 11, 2023	Flow-i C40 Anesthesia System, model 6677400	Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper...	Class II	Getinge Usa Sales Inc
Dec 11, 2023	Flow-i C30 Anesthesia System, model 6677300	Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper...	Class II	Getinge Usa Sales Inc
Dec 11, 2023	Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre...	Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have...	Class II	Globus Medical, Inc.
Dec 11, 2023	ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON...	There is the potential for incomplete staple line formation during the firing sequence, without m...	Class II	Ethicon Endo-Surgery Inc
Dec 11, 2023	Flow-e Anesthesia System, model 6887900	Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper...	Class II	Getinge Usa Sales Inc
Dec 11, 2023	Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep...	Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have...	Class II	Globus Medical, Inc.
Dec 11, 2023	Flow-i C20 Anesthesia System, model 6677200	Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper...	Class II	Getinge Usa Sales Inc
Dec 11, 2023	Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a...	Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have...	Class II	Globus Medical, Inc.
Dec 11, 2023	BrainFeedback Pro 2 Device - is intended as an instrument that provides a vis...	Neurofeedback systems removed due to missing design and development documentation and devices may...	Class II	RONAN MEDICAL LLC
Dec 11, 2023	Flow-c Anesthesia System, model 6887700	Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper...	Class II	Getinge Usa Sales Inc
Dec 11, 2023	Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat...	The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe...	Class II	Olympus Corporation of the Americas
Dec 8, 2023	Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table...	Loss of connectivity between the FlexArm and the Table due to a software issue related to the dat...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023	XScribe Cardiac Stress Testing System, version 6, with below product names an...	Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F...	Class II	Baxter Healthcare Corporation
Dec 8, 2023	Q-Stress Cardiac Stress Testing System, version 6, with below product name / ...	Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F...	Class II	Baxter Healthcare Corporation
Dec 8, 2023	Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reu...	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec...	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.