Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high) Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32 Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low) Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low) Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low) Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and… Software updates Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Massachusetts, Missouri, Pennsylvania, Texas and Wisconsin named
- Medical device recall ARTIS Q, Interventional Fluroscopic x-ray system In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable) Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable… The 9.6F port kits were packaged with the incorrect valved peelable introducer. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 29, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2 Multiple software issues, which may affect the operation and workflow of the system. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, Minnesota, Mississippi, New Hampshire, Texas and Washington
- Medical device recall Panta Nail, Rx only, Sterile Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hitachi Oasis MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Hitachi Echelon Oval MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Hitachi Echelon MRI System Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and… Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 29, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Toshiba Kalare DREX-KL80 X-ray generator It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall Toshiba Ultimax DREX-ULT80 X-ray generator It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin and West Virginia named
- Medical device recall CADD Solis VIP Ambulatory Infusion Pump 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Eclipse Hypodermic Needle BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound Incorrect instructions for use (IFU) included. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU) REF# e2400-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53 The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bencox Mirabo PE Liner 36/44 Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 22, 2017ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is… Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Hemo software In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to… Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration… Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to… Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration… Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Arkon Anesthesia Delivery System Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France Firm received a complaint of the tip holder breaking during use. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes,… Reports that the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The ABL800 Model#:All Reports that the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MaxGuard Extension Set with Injection Site and 0.2 micron filter CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the… Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereMassachusetts and Maryland
- Medical device recall Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of… Class IIFDA’s classMar 22, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Artis Q and Q.Zen fluoroscopic x-ray system A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass 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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