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 Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Artis zee/ zeego systems in case a system error occurs and the system enters the “Bypass Fluoro” mode while the X-ray locking function is active, the only way to exit the X-ray locking… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RenLane Renal Denervation Catheter Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cell Search Circulating Tumor Kit Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bronchial Double Lumen Tube Set (Left), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Bronchial Double Lumen Tube Set (Right), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Bronchial One Lumen Tube - Left Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Bronchial One Lumen Tube - Right Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Carlens Bronchial Double Lumen Tube Set (Left) Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Tracheopart Set (Left), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Tracheopart Set (Right), Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall White Bronchial Double Lumen Tube Set (Right) Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile Customer complaints reporting that the cobb connector detached from the main connector prior to use. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall ADVIA Chemistry Acetaminophen reagents A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radiometer Fixation Kit N20 for the TCM CombiM monitoring system When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner’s surface coating to stick to the surface of the ring. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long Potential for micropores to form, allowing fluid to enter the hollow handle. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge 86 Series Washer/Disinfector with G1 control system software Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, Georgia, Iowa, Idaho, Maryland, Michigan, Minnesota, New York, Pennsylvania, Texas and Washington
- Medical device recall Medtronic EOPA Arterial Cannula EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Michigan, North Carolina, New York, Pennsylvania and West Virginia named
- Medical device recall 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink… The cutting efficiency of the Countersinks was out of specification. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall IBC Suction Wand It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IBC Aortic Punch It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IBC Vascular Loop It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 26, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall rHead Lateral Stem, Size 1, Do Not Reuse, Sterile Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall uHead, Ulnar Implant, Standard Stem, Size 1, Sterile Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit… Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall Xpert CT/NG Urine Specimen Collection Kit Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit… Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of… Charging base of surgical clippers overheats and smokes. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereFlorida, Illinois, Massachusetts, Michigan, Missouri, Pennsylvania and Tennessee
- Medical device recall Siemens Symbia S Series system, a diagnostic analog or digital detector based planar Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report51 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission… Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report51 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission… Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report51 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GE Optional Laser Centering Device X-ray generator. GE has identified a potential failure to comply with 21 C.F.R. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Louisiana, Maryland, New York, Pennsylvania and Washington
- Medical device recall ReSTOR intraocular lens and ReSTOR Toric intraocular lens There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2015ClassClass IStatusTerminatedWhereNo state named
- Medical device recall PathoDx Strep Grouping Kit A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PathoDx Strep B Grouping Latex A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of… Merit Medical Systems, Inc. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932 Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403 Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784 Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191 Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140 Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, 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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