Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2013 | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - l... | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample dil... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2013 | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E... | During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-1... | Class II | Cincinnati Sub-Zero Products Inc |
| May 14, 2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... | Class III | Optovue, Inc. |
| May 9, 2013 | GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... | GE Healthcare has recently become aware of a potential safety issue with respect to the automated... | Class II | GE Healthcare, LLC |
| May 7, 2013 | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Siemens became aware of an unintended behavior when using the Luminos dRF with software version V... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2013 | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with sof... | Siemens has discovered through product monitoring a potential malfunction when using system opera... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Multiple studies were missing at a customer location that never made it to the archive before wat... | Class II | Merge Healthcare, Inc. |
| May 6, 2013 | ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 T... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 25, 2013 | Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device ... | The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is ... | Class II | Hologic, Inc. |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
| Apr 19, 2013 | Centricity Enterprise Archive is a software product for receiving, archiving ... | GE Healthcare has become aware of a potential data loss issue associated with empty path names re... | Class II | Ge Healthcare It |
| Apr 15, 2013 | Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, I... | Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core,... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 9, 2013 | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103... | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the ... | Class II | Alpine Biomed Aps |
| Apr 9, 2013 | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... | GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... | Class II | GE Healthcare, LLC |
| Apr 4, 2013 | Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, im... | When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain ass... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 4, 2013 | Software correction applies to customers who use the RT Therapist RTT4.2.108... | Software update to fix multiple safety related issues. | Class II | Siemens Medical Solutions USA, Inc |
| Mar 31, 2013 | The UF-1000i is a fully automated urine particle analyzer intended for vitro ... | The current Century Break patch did not contain the same setting for the Century Break year for b... | Class II | Sysmex America, Inc. |
| Mar 30, 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a s... | The recall has been initiated due to an overheating protection voltage suppressor on the redundan... | Class II | American Optisurgical Inc |
| Mar 28, 2013 | Integrity 1.1. Integrity is the interface and control software for the Ele... | The problem is that the "static tolerances" from the calibration files (loaded database) are used... | Class II | Elekta, Inc. |
| Mar 20, 2013 | AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Che... | Beckman Coulter, Inc. initiated this recall because there is a software error that has the potent... | Class II | Beckman Coulter Inc. |
| Mar 20, 2013 | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400IS... | HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there a... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Mar 18, 2013 | Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores a... | The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code ... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Mar 15, 2013 | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitat... | Software design error in IMPAX CV 7.8 SU3 | Class II | AGFA Corp. |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici... | Class II | GE Healthcare It |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr... | Class II | GE Healthcare It |
| Mar 8, 2013 | LifeCare PCA infusion system with Hospira MedNet software allows clinicians t... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | The LifeCare Pump Model 4200 PCA Infuser makes possible the practical impleme... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Nu... | Screw rotation error occurring when the pump detects a mismatch between the number of steps given... | Class II | Hospira Inc. |
| Mar 8, 2013 | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license i... | The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC2... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2013 | MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0... | It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown... | Class II | Maquet Cardiovascular, LLC |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The... | The recall was initiated because Carefusion has identified potential risk associated with bolus p... | Class II | Carefusion Corporation |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... | The recall was initiated because Carefusion has received reports of a communication error on the ... | Class I | Carefusion Corporation |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2013 | The LifeCare PCA infusion system with Hospira MedNet software allows clinicia... | The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing.... | Class II | Hospira Inc. |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 26, 2013 | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered ... | In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead... | Class II | Hill-Rom, Inc. |
| Feb 19, 2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of ... | WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock... | Class II | Tecan US, 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.