Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the v... | The observed issues can lead to unexpected interruptions of the optics carrier focus drive moveme... | Class II | Leica Microsystems, Inc. |
| Sep 12, 2017 | i-STAT DE handheld data processing module for clinical use, Software Version ... | Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lis... | Class II | Abbott Point Of Care Inc. |
| Sep 5, 2017 | Patient Positioning System with KRC2 controller using software versions 2.3.1... | Communications between the Patient Positioning System and the accuracy filter can periodically fa... | Class II | Forte Automation Systems Inc |
| Aug 31, 2017 | Syngo.via systems with SW VB20A | A software update was released on August 22, 2017. Performing this software installation and upgr... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the phys... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 31, 2017 | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physic... | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... | Class II | Orthoscan, Inc. |
| Aug 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactu... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 22, 2017 | Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufacture... | Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accu... | Class II | Smiths Medical ASD Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 18, 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software v... | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 14, 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostat... | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Pro... | Class II | Edap Technomed Inc. |
| Aug 14, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, Inc. |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is... | Incorrect source step size may occur in the software plans | Class II | Nucletron BV |
| Aug 7, 2017 | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The ... | The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... | Class II | Merge Healthcare, 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. |
| Aug 3, 2017 | Power Processor 1K Stockyard. The Power Processor performs all pre-analyti... | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can ini... | Class II | Beckman Coulter Inc. |
| Jul 28, 2017 | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... | A software failure may incorrectly set the system settings to "default" settings, creating a risk... | Class II | Roche Diagnostics Corporation |
| Jul 27, 2017 | iVue 500 with iScan, D216606. Product non-contact, high resolution tomogr... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | iVue with Normative Database, Device Listing Number D185549. Product Usage... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 17, 2017 | RayStation Product Usage: is a software system designed for treatment pl... | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout positi... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 14, 2017 | A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 14, 2017 | A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) ... | A software issue may result in the previous settings being applied instead of the default setting... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 13, 2017 | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitor... | Device does not produce a visual or audible impedance respiration APN alarm when an impedance res... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jul 12, 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent card... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 12, 2017 | VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 11, 2017 | Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tom... | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 11, 2017 | Brilliance iCT - Model 728306 Computed Tomography X-ray systems | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 5, 2017 | Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/P... | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... | Class II | Roche Diagnostics Corporation |
| Jul 5, 2017 | cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775... | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Con... | Class II | Roche Diagnostics Corporation |
| Jun 30, 2017 | ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul... | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... | Class II | Alcon Research, Ltd. |
| Jun 30, 2017 | 731 Series Ventilators running software version 05.20.00 The devices in t... | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... | Class II | ZOLL Medical Corporation |
| Jun 30, 2017 | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int... | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... | Class II | Alcon Research, Ltd. |
| Jun 29, 2017 | Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MOD... | Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 17... | Class II | Roche Diagnostics Corporation |
| Jun 27, 2017 | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... | Class II | Hologic, Inc |
| Jun 26, 2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the speci... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jun 20, 2017 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Vers... | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal a... | Class II | Beckman Coulter Inc. |
| Jun 19, 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the... | Class II | Nova Biomedical Corporation |
| Jun 19, 2017 | iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... | Incorrect PEC values. | Class II | Elekta, Inc. |
| Jun 14, 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... | Reports of the device failure involving delivering continuous pressure to the calf garment and no... | Class II | Arjo, Inc. dba ArjoHuntleigh |
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.