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 Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola Accessories assembled, self-contained package LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola Virus Antigen Nasal LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola Virus Antigen Blood LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola Virus GP-VP IgS LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented… Units device head descended unexpectedly Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report46 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital… Units device head descended unexpectedly Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report46 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ROTROL P Control for ROTEM delta Thromboelastometry System Some of vials were found to be partially filled. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci S Surgical System IS2000, Arm Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Camera Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall INFX-8000V Interventional Angiography System The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrument Kit for use with OsteoSponge SC grafts Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU… Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report23 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Texas and Virginia
- Medical device recall CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus… Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry… A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less… Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number… Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereArizona, California and Washington
- Medical device recall CIVCO Surgi-Tip Transducer Cover Sterile Leaks were detected in the recalled lot which may compromise the sterility of the product. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Massachusetts, Michigan, Missouri and Wisconsin
- Medical device recall Vitek 2 AST-P635 The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. Class IIIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 AST-P640 The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. Class IIIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 AST-P641 The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. Class IIIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2015ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report24 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall VasoNova Vascular Positioning System (VPS ) G4 Console A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Georgia, Indiana, Kansas, North Carolina, New York, Pennsylvania and Virginia named
- Medical device recall Boston Scientific: Expel” Drainage Catheter with Twist-Loc” Hub APDL Drainage Catheter and APDL Drainage… Boston Scientific is initiating this Medical Device Field Correction of the Expel” APD and APDL Drainage Catheters. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Louisiana, Maryland, New York, Ohio and Wisconsin
- Medical device recall FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FREEDOMAIRE(R) MOTOR MODULE This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FREEDOMAIRE(R) HELMET WITH MOTOR MODULE This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FREEDOMAIRE(R) HELMET SYSTEM WITH BELT This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LAPAROSCOPIC TUBING SET, 3/16” ¿ X 10’ This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8” x 16’ This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TUBING 7/8’ X 10’, W/WAND & TIP, 24/CS This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VACUUM TUBING 7/8” X 6’ This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VACUUM TUBING 7/8” X 6’ This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TUBING SET 7/8” X 6’ WITH 1/4” x 24” TUBING This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (S) TUBE SET 1/4” X 10’ This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASER RESISTANT WAND - STERILE, 7/8” X 8” This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INTEGRAL WAND W/TUBING, STERILE This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437;… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Skintact ECG Electrode FS-50 The electrodes may fail to transmit signals. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereFlorida
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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