Browse Device Recalls

112 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 112 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 112 FDA device recalls.

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DateProductReasonClassFirm
May 27, 2025 O-arm O2 Imaging System. Mobile X-Ray System. A mechanical component that supports the O2 gantry to the support structure in affected devices m... Class II Medtronic Navigation, Inc.-Boxborough
Dec 4, 2024 Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150M... Due to an increase in complaint that the percutaneous reference pin would not fit into the patien... Class II Medtronic Navigation, Inc.
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.
Apr 26, 2024 O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... Class II Medtronic Navigation, Inc.-Littleton
Mar 26, 2024 Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Use... Due to a software issue, there is the potential for a missing digit, letter, or decimal in either... Class I Medtronic Navigation, Inc.
Nov 28, 2023 Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, Inc.
Nov 28, 2023 Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin una... Class II Medtronic Navigation, Inc.
Sep 27, 2023 StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... Due to a software anomaly which potentially could result in the surgical planning data shifting t... Class I Medtronic Navigation, Inc.
Jul 25, 2023 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... Ground cable installed incorrectly. Class II Medtronic Navigation, Inc.-Littleton
Apr 11, 2023 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... Class I Medtronic Navigation, Inc.
Apr 11, 2023 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... Class I Medtronic Navigation, Inc.
Dec 15, 2022 AxiEM" Non-Invasive Patient Tracker Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints an... Class II Medtronic Navigation, Inc.
Dec 8, 2022 RadiaLux Lighted Retractor (Pink), REF: 50-101-1 Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... Class II Medtronic Navigation, Inc.
Oct 14, 2022 Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10M... Due to a defect in the outer pouch sterile seal Class II Medtronic Navigation, Inc.
Nov 11, 2021 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or ... Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer syn... Class I Medtronic Navigation, Inc.
Nov 9, 2021 Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... Class II Medtronic Navigation, Inc.
Jun 5, 2020 StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437... There is a potential for specific camera units to be affected by a characterization issue during ... Class II Medtronic Navigation, Inc.
Dec 5, 2019 Mazor X Surgical System Positioner Type II, REF: ASM0214-02 There is a potential for the surgical system to detach from the operational room table unexpected... Class II Medtronic Navigation, Inc.
Nov 15, 2019 O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ... Class II Medtronic Navigation, Inc.-Littleton
Oct 30, 2019 Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Aug 28, 2019 NavLock Tracker *** Rx Only Product was incorrectly assembled which could affect navigation accuracy of the device. Class II Medtronic Navigation, Inc.
Aug 9, 2019 Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... Class I Medtronic Navigation, Inc.
Jul 8, 2019 Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: ... The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VC... Class II Medtronic Navigation, Inc.
May 1, 2019 Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX... The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the syst... Class II Medtronic Navigation, Inc.-Littleton
Dec 6, 2018 Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and RE... Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly... Class II Medtronic Navigation, Inc.
Sep 26, 2018 StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cra... An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View usin... Class I Medtronic Navigation, Inc.
Sep 17, 2018 Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... Software anomalies were reported to affect the following system functionalities: startup and shut... Class II Medtronic Navigation, Inc.-Littleton
Jun 1, 2018 Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visu... Class II Medtronic Navigation, Inc.
Mar 23, 2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Num... Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fib... Class II Medtronic Navigation, Inc.
Jan 25, 2018 O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili... Class II Medtronic Navigation, Inc.-Littleton
Sep 30, 2017 O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po... Class II Medtronic Navigation, Inc.-Littleton
Jul 27, 2017 VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visuala... The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Short When used wi... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used wit... Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening o... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, 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.