Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Proteus 235 The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Tennessee and Virginia
- Medical device recall Prosound F75 or F75 The Hitachi Aloka Medical, Ltd Loosened monitor arm. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Indiana, Ohio, Pennsylvania and Texas named
- Medical device recall iConnect Enterprise Archive (ICEA) software The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality… The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement Report35 statesnamed in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical… The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall iConnect Enterprise Archive software. The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOMET 3i LTX DENTAL IMPLANTS A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer,… Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Merge Cardio software using EchoIMS A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Maryland, Missouri, Ohio, Oklahoma, Texas, Vermont and Wisconsin
- Medical device recall AMS-636, 60” Microbore extension set Incorrect priming volume printed on the device package. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is… PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase “This product contains dry natural rubber” and/or… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Cardio software. Cardio study list does not show STAT studies without refreshing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, Indiana, Nebraska, New Mexico and Texas
- Medical device recall ARTISTE” MV System Software update Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mevatron M2/Primus Mid-Energy PRIMUS HI Software update Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ONCOR” Avant-garde Software update Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ONCOR” Expression ONCOR” Impression ONCOR” Impression plus Software update Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional… When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report22 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Texas and Wisconsin
- Medical device recall Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce… Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report22 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Texas and Wisconsin
- Medical device recall Final Fit Software Version 1.11 and 1.12 During treatment planning, the procedure was programmed with an unintended (wrong) correction. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Georgia, Michigan, Minnesota, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates Digital templates were created with the incorrect files. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Merge Cardio software with Issuer of Patient ID (IPID) For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Maryland, Michigan, Missouri, Ohio, Tennessee and Vermont
- Medical device recall Merge Eye Station Import Utility (ESIU) System locks up which may result in potential patient injury or delay in diagnosis or treatment. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency… Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Dakota, Utah, Virginia and Wisconsin named
- Medical device recall EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Incubator The Giraffe Incubator is an infant incubator Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates… Certain power cords could overheat. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been… The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereIowa, Illinois, New York, Ohio, Oklahoma, Pennsylvania, Tennessee and West Virginia
- Medical device recall Poly Component Trial, MPCS The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas and Massachusetts
- Medical device recall Poly Component Trial, UCCS The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas and Massachusetts
- Medical device recall Poly Component Trial, CR The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas and Massachusetts
- Medical device recall Poly Component Trial, PS The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereArkansas and Massachusetts
- Medical device recall Merge Cardio software Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Raindrop Near Vision Inlay ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report29 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Washington
- Medical device recall Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway Labeling error Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Alaris System PC unit Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low) Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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