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 AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADAPTOR, 040 HUM, INTL The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL The packages may contain foreign material (black particles). Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Athrosurface 40mm 13.75x31mm Taper Post Fixation Component Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GemLock Long Hex Driver The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Trellis-6 Peripheral Infusion System A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Covidien Trellis-8 Peripheral Infusion System A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and… This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, New York and South Carolina
- Medical device recall Animas Vibe Insulin Infusion Pump Calibration factors in the pump overwritten during a programming step. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall G- Series Beds Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Missouri, New York and Ohio named
- Medical device recall 16cm Minimally Invasive Attachment Customer complaint indicating the color bands on the MIA16-G1 were not correct. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereCalifornia and North Carolina
- Medical device recall SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a… The interface fails to send abnormal flags for Reference Lab test results. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Kansas, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall MobileDiagnost wDR motorized portable diagnostic X-ray systems. Reports of unexpected movement. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer PERSONA Tibial Articular Surface Inserter Potential for fracture of the tip of the product. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and New York, Ohio, Pennsylvania and Texas named
- Medical device recall ABL90 FLEX analyzer The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement Report41 statesnamed in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereConnecticut and New York
- Medical device recall da Vinci Si Surgical System, IS3000 The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive… Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Plum A+ infusion system pole clamp assemblies were discovered to be cracked. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Potential for delay in surgery and/or ball bearings to be left in the wound. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall SmartSite Low Sorbing Infusion Set CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Ultrasound System The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2 The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Ventilator System Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression,… A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI) This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and… Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall The Revolution CT is a multi-slice A required quality control test was not performed during installation associated with the software of the Revolution CT scanner. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, New York, Utah and Washington
- Medical device recall The Synthes Mandible External Fixator Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate… Potential for failure of the pouch packaging seal at high altitudes. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and… Unintended detector and gantry movement due to software issues. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal… Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear… Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNew York, Utah and Wisconsin
- Medical device recall Ebb Complete Tamponade System, BD-OTS Obstetric Catheter Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ASSY, POWER SUPPLY 130V 50HZ Unqualified power assemblies shipped to customers. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereFlorida and Oklahoma
- Medical device recall Airo Mobile Intraoperative CT I Airo There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error… Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereAlaska, California, Illinois, Massachusetts, North Carolina, New York, Pennsylvania, Texas, Washington and West Virginia
- Medical device recall Zippie Zone Pediatric Rigid Wheelchair There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Maine named
- Medical device recall Quickie Q7 Adult Rigid Wheelchair There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Maine 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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