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 Amplatz Extra Stiff Whisker Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Amplatz Extra Stiff Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Amplatz Stiff Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Amplatz Ultra Stiff Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bentson Cerebral Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bentson Plus Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bentson Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Coons Interventional Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Disposable Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Double Flexible Tipped Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fixed Core Bentson Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Fixed Core Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Movable Core Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Newton Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Rosen Curved Wire Guide Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TFE Coated Curved Newton LLT Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Central Venous Catheter Tray Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Left Atrial Catheter Set Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Femoral Artery Pressure Monitoring Set Label does not state that the product is heparin-coated. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS;… Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Immunoassay Premium Controls The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Immunoassay Premium Plus Controls The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570) Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medical device recall Vial2BagDC, Product Number 6070112 Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device… A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage:… The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall IMRIS ORT100 Table The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMRIS T2X Table The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OneStep CPR Complete, Adult Multi Function Electrodes A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by… Update XL¿ device software to version A.03. Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as… Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Minnesota, North Dakota, New Jersey and Texas named
- Medical device recall Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as… Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Minnesota, North Dakota, New Jersey and Texas named
- Medical device recall NovaKone Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall NovaKone Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden Classic 38 Sphere Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP49 Sphere Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP54 Sphere Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP59 Sphere Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP49 Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP54 Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden Classic 55 Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Alden HP59 Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall ASTERA Multifocal Toric Daily Wear Soft contact Contact lenses lack sterility assurance. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty Product may contain the presence of melted sterile packaging upon opening. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty For soft tissue fixation Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
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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