Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall VITROS Chemistry Products CK-MB Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CRBM Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CREA Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CRP Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products DGXN Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products dHDL Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products ECO2 Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products Fe Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products GLU Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products LAC Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products Li Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products LIPA Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products Mg Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products PHBR Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products PHOS Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products PHYT Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products PROT Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products SALI Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products TBIL Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products THEO Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products TRIG Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products UPRO Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products URIC Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Olympus Endoscopic Flushing Pump There is a possibility that the pump head was not shipped in the locked position. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Centricity Laboratory System is intended to be an information system designed to support the clinical and… GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is The user database delivered for download contained an erroneous value. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zeiss brand IOLMaster 500 The user database delivered for download contained an erroneous value. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography… If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia, Illinois, Indiana, New York and Ohio named
- Medical device recall Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, “***Gelsoft Gelatin Impregnated Knitted… Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereCalifornia and North Carolina
- Medical device recall Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare… 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Vascu Guard, Peripheral Vascular Patch with Apex Processing Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dura Guard, Dural Repair Patch with Apex Processing Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereArizona, California and Ohio
- Medical device recall Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal… The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is… The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereCalifornia, Illinois, North Carolina, New Jersey, New York, South Carolina, Texas and Washington
- Medical device recall ADVIA 1200 System Software: 1) V2.00, 2) V2.01 Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA 1650 System Software: 1) V4.01, 2) V3.52 Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA 1800 System Software V2.01 Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA 2400 System Software V4.01 Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part “Coated VILET *** (Polyglacin 910)… Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereArizona, Florida and Texas
- Medical device recall Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement Report51 statesnamed in where it went PublishedNov 27, 2013ClassClass IStatusTerminatedWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in… The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement Report51 statesnamed in where it went PublishedNov 27, 2013ClassClass IStatusTerminatedWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Spacelabs Healthcare qube Compact Patient Monitor Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Idaho, New York, Oklahoma, Tennessee, Texas and Wyoming named
- Medical device recall CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia… Spacelabs Healthcare Ltd. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and North Carolina and Oklahoma named
- Medical device recall Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass 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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