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 6, 2026.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall GE Discovery MR950 MRI system The alignment lasers are missing the labels required by radiation safety regulations. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall EOS, Digital radiography system used in general radiographic examinations. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Illinois, Indiana, Minnesota, Missouri, Ohio and Pennsylvania
- Medical device recall 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir,… Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has… Class IIFDA’s classMay 13, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereFlorida, New York, Ohio and Texas
- Medical device recall NexGen Augment The affected lot is being recalled because it was packaged without the locking screw. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereFlorida, Illinois, Indiana and Minnesota
- Medical device recall CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom… There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultraview SL Command Modules Modules resetting. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall EPIQ 5 Ultrasound System with Pediatric Cardiology option When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may… Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall EPIQ 7 Ultrasound System with Pediatric Cardiology option When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may… Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall ViewRay System, Radiation Therapy System The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient… Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportMissourithe one state its words name PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E In some cases, the system is unable to capture a clip or image during a routine scan. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ExacTrac 6.x ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch… Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM ARISTOS FX If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B In certain situations, loss of post exercise images can occur in Stress Echo. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 13, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Aspire HD, Full Field Digital, System, x-Ray, Mammographic User Manual lacks a description for handling some errors even though the system can be recovered from such errors Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportHawaiithe one state its words name PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereHawaii
- Medical device recall BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core… The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction… The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. Class IIIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 13, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 119” (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 107” (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 104” (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave,… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 113” (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 108” (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock,… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 127” (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock,… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 98” (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall 98” (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No.… ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, Maryland, Minnesota, North Carolina, South Carolina, Tennessee and Virginia named
- Medical device recall GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Missouri and Wisconsin
- Medical device recall GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Missouri and Wisconsin
- Medical device recall GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Missouri and Wisconsin
- Medical device recall Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Georgia, Illinois, New Mexico, New York and Oregon named
- Medical device recall AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. Product is being recalled due to complaints of cracked frames. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Michigan, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont and West Virginia named
- Medical device recall Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 6, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall MicroScan -Neg Breakpoint Combo Panel Type 34 Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Iowa, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Wisconsin and West Virginia named
- Medical device recall Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder. Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereGeorgia, Indiana, Kansas, Missouri, New York, Pennsylvania, Tennessee and Wisconsin
- Medical device recall MicroScan Pos Combo Panel Type 33 (PC33) Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Kentucky, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VNS Therapy DemiPulse Generator The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Indiana, Michigan, Nevada and Texas
- Medical device recall 9F Plastic Dual Port The dual port with catheters was not covered under FDA clearance. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass 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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