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 |
|---|---|---|---|---|
| Jul 12, 2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay... | Class I | Defibtech, LLC |
| Jul 12, 2024 | Aisys. This anesthesia gas machine is intended to provide general inhalation ... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: ... | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for ... | Class II | GE Healthcare (China) Co., Ltd. |
| Jul 12, 2024 | Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to ... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Aespire 100. This anesthesia gas machine is intended to provide general inhal... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 12, 2024 | Ion Endoluminal System, REF: 380748-65 | There is a potential that the robotic system's instrument cart arm may contain screws that may ... | Class II | Intuitive Surgical, Inc. |
| Jul 12, 2024 | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... | Class I | Datex-Ohmeda, Inc. |
| Jul 11, 2024 | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... | Class II | Medtronic Inc. |
| Jul 10, 2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 10, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RS... | Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatic... | Class II | Beckman Coulter, Inc. |
| Jul 10, 2024 | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended f... | Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within t... | Class II | Bard Peripheral Vascular Inc |
| Jul 10, 2024 | IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a pr... | Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasi... | Class II | Ion Beam Applications S.A. |
| Jul 10, 2024 | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... | Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent r... | Class II | Beckman Coulter Mishima K.K. |
| Jul 9, 2024 | BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solut... | There is a potential risk that the image colony count does not adequately reflect the actual plat... | Class II | Becton Dickinson & Co. |
| Jul 9, 2024 | Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The ... | The weld on the light head frame can crack which could lead to problems such as the light head fr... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Jul 9, 2024 | Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The... | The weld on the light head frame can crack which could lead to problems such as the light head fr... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Jul 9, 2024 | Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The... | The weld on the light head frame can crack which could lead to problems such as the light head fr... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Jul 9, 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| Jul 9, 2024 | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jul 9, 2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... | Class II | Smith & Nephew, Inc. |
| Jul 9, 2024 | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Class II | Covidien |
| Jul 9, 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jul 9, 2024 | TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when u... | Class II | Integra LifeSciences Corp. |
| Jul 9, 2024 | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The ... | The weld on the light head frame can crack which could lead to problems such as the light head fr... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Jul 9, 2024 | BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... | Class II | Medtronic Perfusion Systems |
| Jul 8, 2024 | GM60A. Digital Diagnostic Mobile X-Ray System. | Potential for the anti-fall system of the device arm to fail. | Class II | NeuroLogica Corporation |
| Jul 8, 2024 | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Softwar... | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime | Class II | Ion Beam Applications S.A. |
| Jul 5, 2024 | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Class II | Medtronic Xomed, Inc. |
| Jul 5, 2024 | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Pr... | Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would... | Class III | DRG International, Inc. |
| Jul 4, 2024 | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System | During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifical... | Class II | ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B-Intended to be used as a diag... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with AXIOM Se... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circula... | Devices were labeled with an expiration date of four years and ten days rather than the validated... | Class II | W.L. Gore & Associates, Inc. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with Sensis Hi... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Multitom Rax -Intended to visualize anatomical structures by converting an x-... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Luminos dRF Max- Intended to visualize anatomical structures by converting an... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip... | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). T... | Class II | Zimmer, Inc. |
| Jul 2, 2024 | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... | Class II | Argon Medical Devices, Inc |
| Jul 2, 2024 | Luminos Agile Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telem... | Class II | Stryker Sustainability Solutions |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | W L Gore & Associates, Inc. |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be compromised. | Class II | W L Gore & Associates, Inc. |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
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.