Browse Device Recalls

3,099 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,099 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 3,099 FDA device recalls.

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DateProductReasonClassFirm
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.
Feb 18, 2013 Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 1... A software defect was discovered that causes images to be out of context with clinical information. Class II Ge Healthcare It
Feb 15, 2013 Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brillian... This field change order is being released to update software and customer release notes to the af... Class II Philips Medical Systems (Cleveland) Inc
Feb 15, 2013 RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... Class II RAYSEARCH LABORATORIES AB
Feb 15, 2013 ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... Class III Horiba Instruments, Inc dba Horiba Medical
Feb 12, 2013 Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., Intel... Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with ... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2013 GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ... GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us... Class II GE Healthcare, LLC
Feb 6, 2013 Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The P... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 6, 2013 Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The ... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 6, 2013 Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The P... The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in a... Class II Hospira Inc.
Feb 5, 2013 Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) an... Vital Images has found a potential error in measurement generated through the software which aff... Class II Vital Images, Inc.
Feb 5, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled el... Observed instability of the device. Class II Zimmer Biomet, Inc.
Feb 1, 2013 The Plum A+ Infusion System is a cassette based multifunction infusion system... Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... Class II Hospira Inc.
Feb 1, 2013 The Plum A+ Infusion System is a cassette based multifunction infusion system... Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... Class II Hospira Inc.
Feb 1, 2013 The Plum A+ Infusion System is a cassette based multifunction infusion system... Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The dis... Class II Hospira 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.