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Browse Device Recalls

37 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 37 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 37 FDA device recalls.

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DateProductReasonClassFirm
Apr 30, 2021 Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned... Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 2, 2021 Synapse PACS - Radiological Image Processing System - Product Usage: intended... The wrong patient information may be displayed in the viewer or PowerJacket. Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 18, 2021 ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DC... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 22, 2020 Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... Class III Fujifilm Medical Systems U.S.A., Inc.
Dec 11, 2020 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... The software does not update measurements and calculations in the Clinical Reporting Application ... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020 Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in the viewer or PowerJac... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020 Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a we... FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D ... Class II Fujifilm Medical Systems U.S.A., Inc.
May 22, 2020 Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interfac... Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly... Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 19, 2019 Fujifilm FDR Go Plus mobile X-ray system The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) Class II Fujifilm Medical Systems U.S.A., Inc.
Jan 15, 2019 Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is ... FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspir... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammog... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography Syste... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 4, 2017 Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The ... FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography ... Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 21, 2017 FUJINON ED-530XT. This device is intended for the visualization of the duo... An update to the design and labeling was implemented to help reduce patient risk associated with ... Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 14, 2017 Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s... There was a case that the swivel arm went down unintentionally when it was moved up/down. Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 14, 2017 ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital M... There was a case that the swivel arm went down unintentionally when it was moved up/down. Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 15, 2017 FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary ... A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 17, 2017 Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscop... Fujifilm is recalling multiple endoscopes after a retrospective review. Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 15, 2016 Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx,... Image data for a patients image may not be correct Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 9, 2016 FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Posit... If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent... Class II Fujifilm Medical Systems U.S.A., Inc.
May 10, 2016 Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa... Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Load... Class II Fujifilm Medical Systems U.S.A., Inc.
Apr 1, 2016 Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU Reports of failure of the device's power supply. Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleani... This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 31, 2015 Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED... A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed el... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 30, 2015 Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic ... The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 30, 2015 Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, E... The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position fol... Class II Fujifilm Medical Systems U.S.A., Inc.
Jun 30, 2015 Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For... The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 9, 2015 Fujifilm Endoscope Model ED-530XT Product Usage: This product is a me... Fujifilm is reporting a corrective action due to an FDA inspection. Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 9, 2015 Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 ... Fujifilm is conducting a corrective action due to an FDA inspection. Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 4, 2015 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Ar... Measurement values in the EMR may not accurately reflect the actual measurement value on the Syna... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 4, 2015 Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascu... Under certain circumstances the patient Demographics in a report exported into the EMR may not m... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 3, 2015 Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-10... User Manual lacks a description for handling some errors even though the system can be recovered... Class II Fujifilm Medical Systems U.S.A., 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.