Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 27, 2024 | Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-3... | Incorrect expiration date. | Class II | Safeguard US Operating LLC |
| Aug 27, 2024 | HAWK Warming Grid, Item Number: 59-300 | Incorrect expiration date. | Class II | Safeguard US Operating LLC |
| Aug 27, 2024 | HAWK Advanced Hypothermia Management Set, Item Number: 59-320 | Incorrect expiration date. | Class II | Safeguard US Operating LLC |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/C... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Aug 26, 2024 | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect in... | Class II | Qualigen Inc |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Ca... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Aug 23, 2024 | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing... | Class II | Olympus Corporation of the Americas |
| Aug 23, 2024 | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... | Class II | Stryker Spine |
| Aug 23, 2024 | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... | This recall was initiated due to customer complaints of false negative of hCG test results when r... | Class II | Princeton Biomeditech Corp |
| Aug 23, 2024 | Diode Laser Hair Removal model: WLA-01 | All model WLA-01 systems sold to US customers are found to have labeling non-compliances | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 23, 2024 | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net con... | The bulk product used in the recalling firm's repackaged finished product was recalled due to bac... | Class II | Young Dental Manufacturing I, LLC |
| Aug 23, 2024 | Non-ablative Fractional Laser Systems, Model: WFB-01 | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 un... | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 22, 2024 | System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagno... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 7... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 00... | Potential installation issue that could result in a fire hazard in the event of an interaction be... | Class I | Kinova Inc |
| Aug 22, 2024 | System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 ... | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Res... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 22, 2024 | Healgen Series Reagent strips for Urinalysis are composed of several color pa... | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent S... | Class II | Healgen Scientific Llc |
| Aug 22, 2024 | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stea... | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navig... | Class II | Medtronic Navigation, Inc. |
| Aug 21, 2024 | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading t... | Class II | Medtronic Neuromodulation |
| Aug 21, 2024 | McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 21, 2024 | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2... | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 21, 2024 | Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-... | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not h... | Class II | XTANT Medical Holdings, Inc |
| Aug 21, 2024 | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2024 | Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2024 | Horizon Cardiology Hemo. Version 12.2. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 21, 2024 | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 | It was discovered during device performance testing that the CCD imaging sensors were programmed ... | Class II | Olympus Corporation of the Americas |
| Aug 21, 2024 | da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS50... | Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomi... | Class II | Intuitive Surgical, Inc. |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 20, 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ... | Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar ... | Class II | Ossur H / F |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 20, 2024 | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 | Due to a classification error in our inventory management system, these medical devices were ship... | Class II | Cypress Medical Products LLC |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 19, 2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Versio... | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when use... | Class II | Hologic Inc |
| Aug 19, 2024 | IntelliSystem Inflation Device, REF: IN1525/D | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | StabiliT TOUCH Syringe, REF: IN8VCF/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8140/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | BlueFIRE Inflation Device, REF: IN10140 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixSKY Inflation Device, REF: SKY1802 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 16, 2024 | Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health... | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Windstone Medical Packaging, 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.