Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall AVID TruCustom SPINE convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall AVID TruCustom UPPER EXTREMITY convenience kits Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia and Wisconsin
- Medical device recall The 2nd Assist Knee Positioner Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets… Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog… Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Sterile EXACTAMED Oral Dispenser, Clear, Individually Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL). Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereIllinois, Massachusetts, Maryland, Ohio, South Dakota, Texas, Virginia and Wisconsin
- Medical device recall VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on… VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored… Class IIIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Syngo.via systems with SW VB20A A software update was released on August 22, 2017. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and… A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 7, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed… When the lever of the Insertion Handle is in the “locked” position, the implant may be able to pivot rather than maintaining a rigid connection. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NxStage Dialysate Sack: 1) May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for… A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Surgical punch Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OTTO BOCK Kenevo knee joints Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Washington
- Medical device recall OTTO BOCK Kenevo knee joints Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Washington
- Medical device recall Ultrasound Transducer The ultrasound probe may not have adequate protection against electrical shock hazards. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report21 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia
- Medical device recall Better-Bladder cardiopulmonary bypass blood reservoir The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft… Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Idaho, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Ultra Renew Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Truth Renew Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultra Renew Plus Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Truth Renew Plus Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous… Presence of bacterial endotoxins levels above the acceptable limit Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical… The radiated emission from the TruVidia” Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Indiana, Pennsylvania, South Carolina, Texas, Utah and Virginia
- Medical device recall ST AIA-PACK¿ PROG II, Progesterone II Assay Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report39 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall ST AIA-PACK¿ PROG III, Progesterone III Assay Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report39 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall BC Thrombin Reagent Kit The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Berchtold Chromophare Ceiling Mounted Surgical Light System The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to ‘0’ introduces a discrepancy… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of… Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for… Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a… Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DELTA XTEND” Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use… The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DELTA XTEND” Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in… The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Implantable Cardioverter Defibrillators (ICDs), Evera MRI Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Implantable Cardioverter Defibrillators (ICDs), Evera Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Implantable Cardioverter Defibrillators (ICDs), Visia AF Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall OCULUS Pentacam AXL The device software versions have an anomaly which may produce an erroneous marking for the quality specification value Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and… Potential for failure of the device safety interlock. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to… Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device Robot arm being sent to the wrong position Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania
- Medical device recall ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device Robot arm being sent to the wrong position Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania
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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