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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of… The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values… Class IIIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIIStatusTerminatedWhereConnecticut and Texas
- Medical device recall AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus,… There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereOhio, Texas and West Virginia
- Medical device recall Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a… The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereOhio, Texas and West Virginia
- Medical device recall Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2 The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereOhio, Texas and West Virginia
- Medical device recall Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm Dental implants have incorrect item/lot numbers and size on the inner package labeling. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Georgia, Illinois, Louisiana, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Wisconsin and West Virginia
- Medical device recall Peg Fully Threaded, Locking, 2.5mm x 10mm A size 22mm threaded peg was found in the package of a 10mm unit. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Tibial Alignment Guide Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, New York, Ohio, Oklahoma, South Carolina and Texas
- Medical device recall Foundation Modular Femoral Stem After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereArizona, Missouri, Mississippi, New York, Oklahoma and Utah
- Medical device recall McKesson Cardiology Hemo, Release SW version 13.0 Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Indiana, Kansas, Louisiana, New Jersey, New York, Ohio, Oklahoma, South Carolina and Texas
- Medical device recall Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part… Incorrect use-by date on the device registration/patient file labels. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Nebraska, New York, Ohio, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Nebraska, New York, Ohio, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Nebraska, New York, Ohio, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH” (kit component #52655) attached to the outside of the sterile pack. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia and New Mexico
- Medical device recall PICC Tray, STERILE, 12 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH” (kit component #52655) attached to the outside of the sterile pack. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia and New Mexico
- Medical device recall Laparoscopy CDS One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia and New Mexico
- Medical device recall Cardiac Insulation Pad, OPEN HEART CDS Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia and New Mexico
- Medical device recall LASER CDS Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as “ChloraPrep” (kit component numbers: 29183, 52115, 82279, and 82281). Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereCalifornia and New Mexico
- Medical device recall Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows:… Vials labeled for the prescriptions contained incorrect lenses Class IIIFDA’s classSep 12, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 12, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Illinois, Maryland, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC… Vials labeled for the prescriptions contained incorrect lenses Class IIIFDA’s classSep 12, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 12, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Illinois, Maryland, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Utah
- Medical device recall GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems,… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for… The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VidiStar(TM) PACS & DICOM Viewer Software system The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients… Class IIFDA’s classSep 12, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereArizona, Colorado, Georgia, Illinois, Indiana, Massachusetts, Montana, Ohio, South Carolina and Texas
- Medical device recall WaveCrest Left Atrial Appendage (LAA), Occlusion System When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
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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