Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2023 | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP... | When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam i... | Class II | Ellex Medical Pty Ltd. |
| Mar 14, 2023 | HAMILTON-C6, REF: 160021 | Software error causes, safety ventilation, in which ventilation continues in the "safety ventilat... | Class II | Hamilton Medical AG |
| Mar 13, 2023 | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to pro... | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would no... | Class II | Spectrum Medical Ltd. |
| Mar 8, 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The... | Due to potential software issue that may result in patient mix-up information. | Class II | Radiometer Medical ApS |
| Mar 2, 2023 | Cirq Arm System 2.0 | Risk of mechanical instability due to potential manufacturing error of the device | Class II | Brainlab AG |
| Mar 1, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... | Due to a software issue where the process of patient scanning, the scatter correction may occasio... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 1, 2023 | Instructions for Use for the following Leksell Stereotactic System and Leksel... | The incorrect IFU was distributed with the devices. | Class II | Elekta Instrument AB |
| Feb 21, 2023 | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of ... | Class II | Limacorporate S.p.A |
| Feb 20, 2023 | 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 | There are technical issues related to signal generation and processing, which can lead to inaccur... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 20, 2023 | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained ... | A packaging defect may compromise the sterile barrier. | Class II | Mani, Inc. - Kiyohara Facility |
| Feb 20, 2023 | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | There are technical issues related to signal generation and processing, which can lead to inaccur... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 17, 2023 | Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be... | Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach. | Class II | Arjohuntleigh Magog, Inc. |
| Feb 17, 2023 | Raystation treatment planning system for radiation therapy, Model Numbers 9.0... | It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle wil... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 14, 2023 | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap... | Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a stand... | Class II | Brainlab AG |
| Feb 7, 2023 | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic ex... | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. S... | Class II | Stryker GmbH |
| Feb 6, 2023 | Phoenix mKDR, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | Class II | SEDECAL SA |
| Feb 6, 2023 | Phoenix mKDR Xpress, digital mobile diagnostic x-ray system | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | Class II | SEDECAL SA |
| Jan 25, 2023 | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt ... | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in... | Class II | Limacorporate S.p.A |
| Jan 20, 2023 | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart R... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart R... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 5, 2023 | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... | Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... | Class III | S & MOHR AMERICA, S.A. DE C.V. |
| Dec 23, 2022 | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lat... | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 23, 2022 | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/M... | Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 19, 2022 | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected w... | A software bug eliminated the initial ECG activation and review of the ECG under a physician. How... | Class II | Withings |
| Dec 6, 2022 | Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay... | Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside ... | Class II | Future Diagnostics Solutions B.V. |
| Dec 5, 2022 | Agfa HealthCare Enterprise Imaging XERO Viewer | There is a software defect that can cause issues with images. | Class II | Agfa Healthcare NV |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in ... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 22, 2022 | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality cont... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 22, 2022 | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in... | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... | Class II | Randox Laboratories Ltd. |
| Nov 2, 2022 | The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid ... | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions... | Class II | Qvella Corporation |
| Nov 1, 2022 | IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum... | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... | Class II | Randox Laboratories Ltd. |
| Nov 1, 2022 | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum ... | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... | Class II | Randox Laboratories Ltd. |
| Oct 31, 2022 | Unity Total Knee System. Used for knee prosthesis in total knee replacement | The internal packaging system for devices may have damage to the blisters potentially damaging th... | Class II | Corin Ltd |
| Oct 27, 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... | Class II | Southmedic, Inc. |
| Oct 17, 2022 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-... | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f... | Class II | Visionsense, Ltd. |
| Oct 17, 2022 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Com... | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of f... | Class II | Visionsense, Ltd. |
| Oct 17, 2022 | VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MM... | XXX | Class II | Visionsense, Ltd. |
| Sep 28, 2022 | biokitHSV-2 Rapid Test, REF: 300028001 | HSV-2 rapid test may report false positive results. | Class II | Biokit, S.A. |
| Sep 23, 2022 | GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (... | GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products. | Class II | GAGA PRO LIGHTING EQUIPMENT CO., |
| Sep 22, 2022 | Hamilton-C6 | Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for... | Class II | Hamilton Medical AG |
| Aug 31, 2022 | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... | Class II | Micro-X Ltd. |
| Aug 30, 2022 | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 30, 2022 | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 22, 2022 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... | Weak skin adhesion. | Class II | SenTec AG |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Aug 12, 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... | Due to un-commanded movement of mobile x-ray unit. | Class II | SEDECAL SA |
| Aug 9, 2022 | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Ca... | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, o... | Class I | Jiangsu Well Biotech Co.,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.