Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
Feb 24, 2025 Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... Class II Checkpoint Surgical Inc
Feb 24, 2025 Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... Class II PYRAMES INC
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medline medical procedure kits, containing Medtronic Aortic Root Cannula Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 20, 2025 BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Conne... Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instr... Class II BD SWITZERLAND SARL
Feb 20, 2025 IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... Class II Omnicell, Inc.
Feb 20, 2025 Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... The RSV target may give a late Ct value and could potentially not pass QC. Class II Microbiologics Inc
Feb 20, 2025 Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. Class II Microbiologics Inc
Feb 20, 2025 Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... Class II Orthofix U.S. LLC
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended fo... Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to ... Class I Calyxo, Inc.
Feb 19, 2025 Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCL... There is a potential for the sterility of the device to be compromised. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 19, 2025 GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077... There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... Class II GE Healthcare
Feb 19, 2025 GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203... There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... Class II GE Healthcare
Feb 19, 2025 GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 202229... There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... Class II GE Healthcare
Feb 19, 2025 Lazervida 10W diode laser cutter and engraver with Lazervida shield. Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in ... Class II Flux Technology Inc.
Feb 19, 2025 Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model ... There is a potential for the sterility of the device to be compromised. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 19, 2025 GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;... There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... Class II GE Healthcare
Feb 19, 2025 MIM software; System, Image Processing, Radiological In situations where two images with differing Fields of View (FOV) complete an image fusion, an i... Class II MIM Software Inc
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... When following a specific less typical workflow in which the user remeasures using the ultrasound... Class II Merge Healthcare, Inc.
Feb 19, 2025 GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numb... There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... Class II GE Healthcare
Feb 18, 2025 GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 18, 2025 GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 GE Healthcare Revolution CT, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... Class II GE Medical Systems, LLC
Feb 18, 2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 17, 2025 Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-M... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RE... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-M... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive saf... Increased risk for valve housing detachment causing leakage. Class II B Braun Medical Inc
Feb 17, 2025 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-T... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-T... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)

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.