Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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 7, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall MUM-1 (Multiple myeloma oncogene-1) Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Illinois, Louisiana, Massachusetts, Missouri, New York, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740 Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereColorado, Connecticut, Mississippi, New Jersey, New York, Ohio and Washington
- Medical device recall VITROS 3600 Immunodiagnostic System Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EXp Tibial Insert Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Indiana, Kansas, Maryland, New York, Pennsylvania, Texas and Washington
- Medical device recall SOMATOM Force Artifacts are found in acquired imaging on the SOMATOM Force. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereMassachusetts, Maryland, Minnesota, Pennsylvania, South Carolina and Texas
- Medical device recall Artis Q, and Artis Q.zen ceiling systems Suboptimal routing of the cable may result in increased wear over time. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Malleable C- Retractor Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep… A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium… A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used… A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall lnline Persuader- PedFuse Pedicle Screw System A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Ohio, Texas and Virginia named
- Medical device recall Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07 The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArizona, California, New York, Puerto Rico, Tennessee and Texas
- Medical device recall Various Brilliance and Ingenuity Computed Tomography X-ray systems Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR… Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental… Drill set may contain incorrect drill. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, Virginia and West Virginia named
- Medical device recall Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113 The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArizona, California, New York, Puerto Rico, Tennessee and Texas
- Medical device recall Timberline Anchored Lateral Fixed Retractable Sleeve The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArizona, California, New York, Puerto Rico, Tennessee and Texas
- Medical device recall GE Healthcare Revolution CT., multi-slice Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, New York, Utah and Washington
- Medical device recall The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with… Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The… Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather… Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries. The devices were not shipped with the Starter Kits. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri, Pennsylvania and Wisconsin
- Medical device recall Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and… The product (wool wrist loop) was manufactured 7cm shorter than product specifications. Class IIFDA’s classJan 21, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 21, 2015ClassClass IIStatusTerminatedWhereArizona, Missouri, Pennsylvania and Wisconsin
- Medical device recall Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option Incorrect lumi firmware version installed (E.027 instead of V2.00) Class IIIFDA’s classJan 21, 2015in FDA’s Enforcement ReportMarylandthe one state its words name PublishedJan 21, 2015ClassClass IIIStatusTerminatedWhereMaryland
- Medical device recall Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option Incorrect lumi firmware version installed (E.027 instead of V2.00) Class IIIFDA’s classJan 21, 2015in FDA’s Enforcement ReportMarylandthe one state its words name PublishedJan 21, 2015ClassClass IIIStatusTerminatedWhereMaryland
- Medical device recall Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR… In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT)… In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2… In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ABX PENTRA Reagent Container HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments… ATTUNE INTUITION Impactors (cat. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Rotating Tibial Platform ATTUNE INTUITION Impactor ATTUNE INTUITION Impactors (cat. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Femoral Impactor ATTUNE INTUITION Impactor ATTUNE INTUITION Impactors (cat. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3 Mislabeled Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ti-Bond Marketing Literature/Labeling Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within… Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill… Use of excessive force when impacting may lead to intra-operative femoral fracture. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Indiana, Louisiana, North Carolina, New Jersey, Texas and Wisconsin
- Medical device recall McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze,… An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereMassachusetts, Mississippi, North Carolina, New Hampshire, Texas and Washington
- Medical device recall The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in… Siemens Medical Solutions USA, Inc. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in… Siemens Medical Solutions USA, Inc. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction… Siemens Medical Solutions USA, Inc. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the… There is a potential for patient finger injury on the e.cam systems. Class IIFDA’s classJan 14, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes Class IIFDA’s classJan 14, 2015in FDA’s Enforcement Report25 statesnamed in where it went PublishedJan 14, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin
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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