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 5, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Philips Healthcare Xper vascular system Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Xper cardio systems R7.6 Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare Xper vascular systems R7.6 Monitor Ceiling Suspension system may fall Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387 The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereMontana and New York
- Medical device recall ProTrack Microcatheter Microcatheter may have circumferential defects (cracks) along its shaft. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IOL Master 5.5: Software versions 7.5 and 7.7 IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IOL Master 500: Software versions 7.5 and 7.7 IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Altrus Thermal Tissue Fusion Energy Sources Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece’s… Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereCalifornia and Texas
- Medical device recall Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft The products have been found to intermittently exhibit a seal failure during use. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging’s Tyvek lid(s). Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile… Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereConnecticut, Massachusetts, Missouri and North Carolina
- Medical device recall Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost The hook does not securely hold the footplate in vertical position. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereArizona, Connecticut, Florida, Hawaii, Kentucky, Massachusetts, Minnesota, North Carolina, Texas, Virginia and Wyoming
- Medical device recall Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost The hook does not securely hold the footplate in vertical position. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereArizona, Connecticut, Florida, Hawaii, Kentucky, Massachusetts, Minnesota, North Carolina, Texas, Virginia and Wyoming
- Medical device recall Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1 The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall PROLARYN Injectable Implant 1.0 cc Gel The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 2, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Syngo Imaging VB36D_HF02 To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNorth Carolina, Nebraska and Ohio
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and… Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool The wire pass hole is not present on the tools. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereCalifornia, New York and Texas
- Medical device recall Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml. Class IIIFDA’s classDec 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 2, 2015ClassClass IIIStatusTerminatedWhereCalifornia and Washington
- Medical device recall 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report27 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia
- Medical device recall SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System SCFE Driver’s threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereFlorida and Tennessee
- Medical device recall Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi… When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage System One S Cycler (High Permeability Hemodialysis System) Ultrafiltration (UF) Volume software error inaccurate fluid removal Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage System One S Cycler (High Permeability Hemodialysis System) Ultrafiltration (UF) Volume software error inaccurate fluid removal Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics… CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package… Class IIIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Palindrome” Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac” Stylet 14.5 Fr/Ch Incorrectly packaged with a 90 degree bend at the distal tip Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch Incorrectly packaged with a 90 degree bend at the distal tip Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac” Stylet 14.5 Fr/Ch Incorrectly packaged with a 90 degree bend at the distal tip Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac” Stylet 14.5 Fr/Ch Incorrectly packaged with a 90 degree bend at the distal tip Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac” Stylet 14.5… Incorrectly packaged with a 90 degree bend at the distal tip Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD CD64 APC-R700 Three lots of CD64 (MD22) are contaminated with CD4 antibody. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereFlorida, Georgia, Iowa, Illinois, North Dakota, Pennsylvania, Rhode Island, Texas and Washington
- Medical device recall NxStage System One S Cycler Ultrafiltration Volume (UFV) may not decrease during treatment-software error. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NxStage System One S Cycler Ultrafiltration Volume (UFV) may not decrease during treatment-software error. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NxStage System One S Cycler -High Permeability Hemodialysis System Ultrafiltration Volume (UFV) may not decrease during treatment-software error. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall rainbow Reusable Sensors These sensors were manufactured with incompatible configurations. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista System (MG) Erroneous low results on a small number of reagent wells. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c… Class IIFDA’s classDec 2, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Indiana, Louisiana, Michigan, Minnesota, New Mexico, New York and Ohio
- Medical device recall Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10) These Lot numbers are not stable up to the expiry date on the product labeling. Class IIFDA’s classDec 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspiration Ventilator System, i Series and LS 12.1 LCD A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Easy Dial Oxygen Regulator, 168708D and 168715D These lots of Oxygen Dial Regulators could have the settings label off by one position. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Idaho, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New York, Ohio, Oklahoma, Pennsylvania and Texas
- Medical device recall ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized… When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GMK Hinge knee prosthesis Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereIllinois, Ohio and Utah
- Medical device recall Synthes Application Instrument for Sternal ZIPFIX Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Nebraska, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Washington and Wisconsin
- Medical device recall Taut Intraducers 10/BX7.5 FR 3.5 The defective component can cause gas leakage through the device. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
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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