Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2023 | NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Del... | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the... | Class I | NOXBOX LTD |
| Apr 27, 2023 | Intelli-C, Right side suspended Tabletop, REF: 03400000 | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... | Class II | NRT X-RAY A/S |
| Apr 27, 2023 | Intelli-C, Left side suspended Tabletop, REF: 03400010 | There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... | Class II | NRT X-RAY A/S |
| Apr 26, 2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... | Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel... | Class II | HeartSine Technologies Ltd |
| Apr 26, 2023 | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... | The wrong tibia guide was included intended for a different patient case. | Class II | Materialise N.V. |
| Apr 10, 2023 | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... | Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Mar 31, 2023 | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... | The liquid buffer component in the affected test kit lots was determined to have bacterial contam... | Class I | SD Biosensor, Inc. |
| Mar 28, 2023 | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 28, 2023 | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 27, 2023 | TDHisto/Cyto - A software product used for managing medical information in th... | In a specific use case, when printing labels for slides, some labels may display wrong information | Class II | Technidata S.A. |
| Mar 24, 2023 | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... | Class II | Richard Wolf GmbH |
| Mar 24, 2023 | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... | Class II | Richard Wolf GmbH |
| Mar 24, 2023 | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... | Class II | Richard Wolf GmbH |
| Mar 24, 2023 | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... | Class II | Richard Wolf GmbH |
| Mar 21, 2023 | Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.... | Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 16, 2023 | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL... | JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disas... | Class II | SPINEART SA |
| 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. |
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.