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 Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue Wand Handpiece was mislabeled as STA handpiece. Class IIIFDA’s classJul 8, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 8, 2015ClassClass IIIStatusTerminatedWhereFlorida, Illinois, New York, Puerto Rico and Washington
- Medical device recall Dr. Sheffield’s LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant. Recovery of high count of gram positive rods including single colonies of B. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kansas, Michigan, Minnesota, North Carolina, New Jersey, New York and Puerto Rico
- Medical device recall Treatment Planning and Delivery System Software version 3.6 The software was failing to determine new patient locations if imaging is not enabled during treatment. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Missouri and Wisconsin
- Medical device recall JustRight 5mm Stapler, JR-ST25-2.0 Stapler is JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JustRight 5mm Reload, JR-REL25-2.0 Reload is JustRight Surgical is recalling various lots of JustRight 5mm Stapler product because they may deliver incomplete staple formation and incomplete tissue… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CentraLink” Data Management System Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical… under certain circumstances the Cios Alpha system may freeze during a procedure. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Spine Wave Access Kit Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Oregon, Pennsylvania, Texas and Virginia named
- Medical device recall The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes,… D50 and D51 Diagnostic error codes are not functional. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes,… D50 and D51 diagnostic error codes are not functional. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Hamilton Medical Infant Flow Sensor, single use An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hamilton Medical Infant Flow Sensor, single use An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hamilton Medical Infant Flow Sensor, single use An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Infinite F500, in vitro diagnostic A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Infinite M1000 PRO in vitro diagnostic A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Infinite M1000 in vitro diagnostic A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Infinite 200 PRO in vitro diagnostic A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Infinite 200 in vitro diagnostic A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall SYNGO IMAGING (VERSION V30 and V31) During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNorth Carolina and Nebraska
- Medical device recall GE Healthcare Optima IGS 320 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Discovery IGS 730 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova 2100IQ GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova 2121IQ GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova 3100IQ GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova 3131IQ GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova IGS 520 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova IGS 530 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova IGS 540 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova IGS 620 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Innova IGS 630 GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare Optima CL 323i GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use… The intake port may be blocked which can cause the bag to fail to fill. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 1, 2015ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012 There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Idaho, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall Steriseal-Cannula Ophthalmic The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Pennsylvania named
- Medical device recall Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with… Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Minnesota and Pennsylvania
- Medical device recall ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair. Sterility of device maybe compromised Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Fortex” Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville… The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereFlorida, Idaho, Illinois, Kansas, Louisiana, Michigan, Missouri, New Jersey, Ohio, Pennsylvania and Texas
- Medical device recall McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to… Small sized specula were incorrectly packaged in printed bags for the medium sized speculum Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Massachusetts, Missouri, Texas and Washington named
- Medical device recall GE Healthcare, Treadmill T2100 GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Merit Medical Prelude Pro Sheath Introducter, 6F Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereMassachusetts, Nebraska, South Carolina, Tennessee, Utah and Wisconsin
- Medical device recall NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Bacterial contamination. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Cardiovascular Procedure Kits The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. Class IIFDA’s classJul 1, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereFlorida and Missouri
- Medical device recall Surface Applicator Set with Leipzig-style Cone Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator’s Instructions for Use (IFU): Dose… Class IIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2015ClassClass IIStatusTerminatedWhereNo state 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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