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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 26, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Optiflux F160NR Capillary High Flux Dialyzer Single Use Only Potential for external blood leaks from the dialyzer header Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bucky Stand SU-4000 Input 2017.11.17 Unintentional U-Arm movement Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall CIVCO Needle Guide Bracket The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Bracket The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Biopsy Bracket Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SonoSite Needle Guide Bracket Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SonoSite FUJIFILM Needle Guide Bracket Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Starter Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Bracket Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide Bracket Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Sales Demo Kit Recalled by FDA on Dec 19, 2018 Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private… A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label:… A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label:… A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label:… A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber… A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Medtronic HeartWare Ventricular Assist HVAD System Battery Charger HVAD Battery Charger units manufactured with wrong inductors. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall PROCARE B20 Patient Monitor, V1 Patient monitors may restart due to network overload caused by network configuration. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall PROCARE B40 Patient Monitor, V1 Patient monitors may restart due to network overload caused by network configuration. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall B20i Patient Monitor and B20i V2 Patient Monitor Patient monitors may restart due to network overload caused by network configuration. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for… Patient monitors may restart due to network overload caused by network configuration. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall B105/125 Patient Monitor Patient monitors may restart due to network overload caused by network configuration. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE LOGIQ E10 Ultrasound System There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Illinois, Massachusetts, Maine, Minnesota, Montana, Pennsylvania, Texas and Washington named
- Medical device recall ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a… Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and West Virginia named
- Medical device recall Orthopedic Salvage System (OSS) Porous Stem Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereIndiana, Maryland, Missouri, Mississippi and New Mexico
- Medical device recall Comprehensive Mini Stem Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereIndiana, Maryland, Missouri, Mississippi and New Mexico
- Medical device recall IntelliVue MX40 Patient Monitor A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086… The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Pennsylvania and Washington named
- Medical device recall Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES… Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG) Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch This voluntary recall is being conducted due to incorrect packaging. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UroLift System Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report44 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall AIA-2000 Analyzer Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIA-900Analyzer Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemoglobin A1c Control Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. Class IIIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or… The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HeartStart MRx, Rechargeable Li-Ion (lithium ion battery) Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report32 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Binding Site Human IgM Kit (for SPAPLUS) Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Nebraska, New York, Pennsylvania, South Dakota, Virginia and Washington
- Medical device recall Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Discovery NM/CT 670 DR When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 19, 2018ClassClass IIStatusCompletedWhereCalifornia, District of Columbia, Ohio, Utah and Wisconsin
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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