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 PFR Kit- Pinnacle, Posterior Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Uphold Vaginal Support System Potential for Capio sutures to break and /or detach. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the… Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report31 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington and Wyoming
- Medical device recall Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has… Incorrect gel part number listed in a master manufacturing record Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportRhode Islandthe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereRhode Island
- Medical device recall Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product… Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and West Virginia named
- Medical device recall Thumper Cardiopulmonary Resuscitator A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the… Class IIIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 16, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Neonatal PICC Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Maximum Barrier Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Maximum Barrier Insertion Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system. Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Maximum Barrier Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall PICC Insertion Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall PICC Insertion Tray Potential friction holes may affect the sterility of the product. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Massachusetts, Minnesota, Missouri, New Jersey, Pennsylvania, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARDIOHELP Gas Bottle Holder HKH 8880 There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall BECKMAN COULTER iChemVELOCITY, Urine Chemistry System Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. Incorrect product and/or label. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report32 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wyoming
- Medical device recall IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI… The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, New Hampshire, Ohio and Texas named
- Medical device recall ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall ADVIA Salicylate (SAL) reagent chemistry assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Ammonia (AMM) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Alanine Aminotransferase (ALTI) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark,… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark,… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics,… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Alanine Aminotransferase (ALTI) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Aspartate Aminotransferase (AST) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Glucose (GLU) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Creatine Kinase MB (MBI) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Dimension Vista Thyroxine (T4) assay Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics,… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics,… Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter… Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter… Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter… Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter… Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter… Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L,… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass 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.”
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