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 Tool, Stripper W/BLD, 18S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 18S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 44S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 44S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 28S, Nonautoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tool, Stripper W/BLD, 28S, Autoclavable validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective… validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective… validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective… validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective… validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bone Marrow Aspiration Needle 15G x 2.688 MAX Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereFlorida and Puerto Rico
- Medical device recall American Catheter / Cholangiogram Catheter 9100 Series. Catheters were not sealed before sterilization. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report21 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Missouri, Montana, New Jersey, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall HardyCHROM VRE Agar-RSR Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall GEMINI GXL 16 Slice CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI LXL CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI TF 16 Slice CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI TF 64 Slice CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI TF Ready CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI TF Base CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEMINI TF Big Bore CT/PET System Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6 Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall iovera 155 Smart Tip The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Maryland, New York and Texas named
- Medical device recall ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In… The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, New York and Wisconsin named
- Medical device recall Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall ADVIA Centaur Tni-Ultra Assay System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, 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, West Virginia and Wyoming named
- Medical device recall Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek… Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Massachusetts, Michigan, Missouri, Nebraska, New York, Pennsylvania, Rhode Island, Texas, Virginia and Wisconsin
- Medical device recall A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw Sterile packaging was not sealed. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Altiva / Exactech Spine, Large Set Screw Incorrect thread form on the screw. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, New York, Texas and Washington
- Medical device recall ZNN Antegrade Femoral Nail (ZNN AF) A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereAlaska and North Carolina
- Medical device recall IMPAX Agility Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportMissourithe one state its words name PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall 0210-312-000-Woundcare Replacement kit with soft tip Potential sterility breach in the packaging. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, Illinois, Indiana, Louisiana, Maryland, Minnesota, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for… A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Idaho, Illinois, Missouri, North Carolina, New Jersey, New York, Oregon, South Carolina, Tennessee and West Virginia
- Medical device recall Apex ARC Hip Stem, HA Coated, Size 5 Product may breach the inner and outer sterile pouches during shipping or handling. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Massachusetts, Oklahoma, Texas, Utah, Virginia and Wyoming named
- Medical device recall Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Indiana, North Carolina, Ohio and Pennsylvania named
- Medical device recall G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7 The G7 Variant Elution Buffer HiS no. Class IIIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Idaho and Puerto Rico named
- Medical device recall Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser… Accessories to the GYC-1000 laser were missing Laser Aperture labels. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Oregon, Rhode Island, Texas, Utah, Washington and Wisconsin
- Medical device recall Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System Accessories to the GYC-1000 laser were missing Laser Aperture labels. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Oregon, Rhode Island, Texas, Utah, Washington and Wisconsin
- Medical device recall Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for… Shipped to a single consignee prior to completion of final inspection. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended… Shipped to a single consignee prior to completion of final inspection. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medical device recall A.L.P.S. - Medium Bone Plate Forceps Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Georgia, Indiana, Kentucky, Massachusetts, Missouri, North Carolina, New Jersey, South Dakota and Texas
- Medical device recall Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips… The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Georgia and Pennsylvania named
- Medical device recall Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No.… One dimension of the affected instrument is incorrect. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the… Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.