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 7, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Optilite IgG4 Kit A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct… Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, Florida, Massachusetts, Michigan, Pennsylvania, Texas and Washington
- Medical device recall cobas p 612 pre-analytical system Recalled by FDA on Feb 1, 2017 Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereTexas and Washington
- Medical device recall Merge Hemo software There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High… Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Kansas, Massachusetts, Missouri, New Jersey, New York, Pennsylvania and Washington named
- Medical device recall Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report21 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, North Carolina, North Dakota, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide… Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide… Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hitachi Oasis MRI System - C-Spine Coil The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedFeb 1, 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, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in… Software error. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Softbank software Product Usage: Decision support software for transfusion service Software error. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Accu-Chek Connect Diabetes Management App iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The… AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product… AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The… AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus Product resistance has fallen outside of label claim within expiry. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Iowa, Missouri, North Carolina, Nebraska, New York, Ohio and Washington
- Medical device recall NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of… Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Cisco 3850 layer 3 switch, 865339 May experience a loss of centralized monitoring. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Florida, Georgia, Kentucky, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Alaris Pump Module During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Halo One 5F Introducer Sheath 45 cm Complaints of sheath separation, kinking, and/or tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide, and Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, New Hampshire, Nevada, New York, Ohio, Texas, Utah and Washington named
- Medical device recall Halo One 5F Introducer Sheath 90 cm Complaints of sheath separation, kinking, and/or tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide, and Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, New Hampshire, Nevada, New York, Ohio, Texas, Utah and Washington named
- Medical device recall Halo One 5F Introducer Sheath 10 cm 5 pack Complaints of sheath separation, kinking, and/or tip damage during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide, and Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, New Hampshire, Nevada, New York, Ohio, Texas, Utah and Washington named
- Medical device recall MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro… A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is… A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 25, 2017ClassClass IStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Optilite Analyser Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Georgia, Kentucky, Michigan, North Carolina, New Jersey, New Mexico, New York, Pennsylvania and Virginia named
- Medical device recall Medacta International SA, M.U.S.T Damaged packaging, lack of sterility assurance Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Texas named
- Medical device recall RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323… Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152 Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 2008T Series Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 2008K Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 2008K2 Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius 2008K@home Series : Hemodialysis System When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15. Products were labeled with incorrect Global Trade Item Numbers. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee and Virginia
- Medical device recall AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D.,… Products were labeled with incorrect Global Trade Item Numbers. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee and Virginia
- Medical device recall Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Products were labeled with incorrect Global Trade Item Numbers. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report13 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee and Virginia
- Medical device recall PREMIER EHEC and PREMIER EHEC Bulk. Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report38 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that… Ultradent Products, Inc. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AFX Endovascular AAA System, Endoleak Type IIIA Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts… Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AFX Endovascular AAA System, Endoleak Type IIIB Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts… Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AutoMate 2500 Family Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10. Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportMarylandthe one state its words name PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereMaryland
- Medical device recall Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy Lack of 510k clearance for design modification. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit Lack of 510k clearance for design modification. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optilite Freelite Lambda Free Kit Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Georgia, Kentucky, North Carolina, Pennsylvania and Virginia
- Medical device recall Monaco RTP System Incorrect dose after editing beam number an wedge angle. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report27 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use… A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report27 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Merge Cardio software If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended… Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2017ClassClass 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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