Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 1, 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... | Class II | Nidek Inc |
| Jun 28, 2016 | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with softw... | In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be un... | Class II | B-K Medical A/S |
| Jun 23, 2016 | Syngo.via, picture archiving and communications system software controlled. ... | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2016 | Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... | Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 22, 2016 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical ... | Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in tes... | Class II | Olympus Scientific Solutions Americas |
| Jun 22, 2016 | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... | Risk associated with operating the device in skin temperature mode with temperature sensors attac... | Class II | Draeger Medical, Inc. |
| Jun 16, 2016 | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 14, 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... | WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... | Class II | WalkMed Infusion, LLC |
| Jun 14, 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Fou... | WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 30000... | Class II | WalkMed Infusion, LLC |
| Jun 6, 2016 | SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... | Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... | Class II | Siemens Medical Solutions USA, Inc |
| May 26, 2016 | ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... | Eight (8) issues were identified which may affect the results generated by the system software ve... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 26, 2016 | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... | Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| May 25, 2016 | BrightView X, model #882478; gamma camera designed for single or dual detecto... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Upgrade Model 882454 | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed... | The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 25, 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Ha... | Software displayed incorrect prior reports in the viewport area, only when more than one prior st... | Class II | Merge Healthcare, Inc. |
| May 18, 2016 | Proteus 235 and Proteus ONE proton therapy systems | Recall is being initiated to address on-site software installations not being performed consisten... | Class II | Ion Beam Applications S.A. |
| May 16, 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enG... | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numeri... | Class III | Ortho-Clinical Diagnostics |
| May 12, 2016 | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr... | A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea... | Class II | CareFusion 303, 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. |
| May 9, 2016 | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... | Software error in previous software versions in which two references for the same image may exist... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2016 | Ariol is an automated scanning microscope and image analysis system. It is in... | An issue during the manufacturing process caused systems to have an improperly activated Windows ... | Class III | Leica Biosystems Richmond Inc. |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... | Class II | Volcano Corporation |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 15, 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge... | There are potential issues with results reporting for certain run-based tests. Under certain con... | Class II | Merge Healthcare, Inc. |
| Apr 15, 2016 | Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Apr 15, 2016 | Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... | Class III | Affymetrix Inc |
| Apr 13, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... | Class II | Merge Healthcare, Inc. |
| Apr 12, 2016 | Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... | Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... | Class II | Toshiba American Medical Systems Inc |
| Apr 11, 2016 | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteu... | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and ... | Class II | Ion Beam Applications S.A. |
| Apr 11, 2016 | TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25... | Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient ... | Class II | Echopixel, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS | Reports were missing demographic header information when they were faxed to referring physicians. | Class II | Merge Healthcare, Inc. |
| Apr 8, 2016 | ROSA Surgical Device 2.5.8 | Potential for software to change the final tool orientation for the command position without comm... | Class II | Zimmer Biomet, Inc. |
| Apr 8, 2016 | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... | While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... | The software is not adding the correct tomo image. | Class II | Merge Healthcare, Inc. |
| Apr 6, 2016 | Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ... | If used, the optional Swap feature copies programming parameters from the external pulse generato... | Class II | Nuvectra |
| Apr 6, 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 4, 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... | In some instances, the system will lock tabs within a study, even when a second user does not hav... | Class II | Merge Healthcare, 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.