Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation… Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Missouri, Mississippi, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereIllinois, New Jersey and Pennsylvania
- Medical device recall Omega Incline Platform Lift Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate… Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to… Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration… Class IIFDA’s classMay 3, 2017in FDA’s Enforcement Report21 statesnamed in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington and Wisconsin
- Medical device recall The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs. Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SmartSite Add-On Bag Access Device CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 5.5mm Diameter x 500mm CoCr Straight Rod The material type on the label may incorrectly state Ti6Al-4V ELI . Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Georgia, Louisiana, Nevada, Ohio and Texas named
- Medical device recall 01.4mm x 457mm Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereGeorgia, Kansas and Texas
- Medical device recall Stryker SmartLife Large Aseptic Housing Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of… Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731 Potential for biased results generated using the specific lots of VITROS VANC Reagent. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 3, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage:… Confirmed complaint of surface contamination of Listeria monocytogenes. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Colorado, Iowa, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Ohio, Oklahoma, Puerto Rico, South Dakota and Texas named
- Medical device recall 1 mL Medallion¿ Syringe Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allura Xper Release 8.2 (Laird chiller is always installed) Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UNIQ: UNIQ FD10 722026 Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The following systems are only affected if a Laird chiller is installed Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tapered SwissPlus Implant System It was manufactured with the minor diameter of the internal thread that is below specification. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Artis zee, Angiographic x-ray system Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereCalifornia, Virginia and Wisconsin
- Medical device recall Hemotherm CE Improperly rated fuses were used in the manufacture of the device. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report25 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Cordis S.M.A.R.T Deployment Difficulty. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ferno PROFlexx¿ The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Hawaii, Illinois, New York and Ohio
- Medical device recall Merge Eye Station and Merge Eye Care PACS. During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow EZ-IO Needle Set 45 mm 15 ga Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. Class IIIFDA’s classApr 26, 2017in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 26, 2017ClassClass IIIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, 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, West Virginia and Wyoming
- Medical device recall Proteus 235, Proton Therapy System In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportLouisianathe one state its words name PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereLouisiana
- Medical device recall NEODENT CM Intraoral Scanbody, Article Number: 108.139 During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereArizona, California, Illinois, New Jersey, Nevada, Pennsylvania and Texas
- Medical device recall Access Ferritin Calibrators Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Soft Face “No Bounce” Mallet Potential for poly tip of the mallet to come off during use. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight Incorrect device was packaged. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, New York, Ohio, Pennsylvania and Utah named
- Medical device recall Valleylab Laparoscopic Handset Customer reports of the device handset continuing to operate after release of the activation button. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and… Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated that there is potential for sterile packaging to be compromised. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde… Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall It is recommended for patients with weight/size between 4-22 lbs Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)). Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NAMIC Fluid Delivery Set - 72” The product has the potential to be non-sterile as it was not packaged in accordance to specification. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Maryland, Oregon, Texas and Virginia
- Medical device recall Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall D-RAD, 2.4MMX 20MM, S.T The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass 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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