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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Affixus Hip Fracture Nail Right 130 11 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 130 11 mm x 400 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 130 13 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 130 9 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 130 11 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 130 11 mm x 380 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 130 11 mm x 400 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 130 15 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail 125 9 mm x 165 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Mindray BeneVision The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Massachusetts, New York, Pennsylvania, Puerto Rico, Texas and West Virginia
- Medical device recall Gibco MEM Non-Essential Amino Acids Solution Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gibco Sodium Pyruvate Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use Leaky bottles due to a defect in the bottle cap compromising the sterility of the product Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart FR3 Defibrillator Automated external defibrillators may not fully meet IPx5 water ingress specification. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Nebraska, New York and Washington named
- Medical device recall Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System The service manual was not updated at the time of the release of software version 1.30. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon… The terminals on the plug may become loose and overheat. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S The terminals on the plug may become loose and overheat. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reinforced Dual Lumen Cannula, 13Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Reinforced Dual Lumen Cannula, 16Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Reinforced Dual Lumen Cannula, 19Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Reinforced Dual Lumen Cannula, 23Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ECMO Reinforced Dual Lumen Cannula, 28Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Reinforced Dual Lumen Cannula, 32Fr. These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Atellica Sample Handler Prime (SMN 11069001) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica Sample Handler Connect (SMN 11069018) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica Sample Handler Additional (SMN 11069004) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1300 Analyzer (SMN 11066001) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer (SMN 11066000) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH 930 Analyzer (SMN 11067000) Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED BioFlo Ports was partially manufactured with the incorrect sterile port assembly. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Indiana named
- Medical device recall Hemosll ReadiPlasTin There is a potential for increased imprecision, out of range quality controls and prolonged sample results. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INSORB SUBCUTICULAR SKIN STAPLER Possible compromise of the sterile barrier integrity Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative… Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect… Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Integrated System- (Refurbished) Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect… Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station The device may not function at the lower end (<15 deg. Class IIIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Michigan, North Carolina and New York
- Medical device recall Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the… Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Minnesota and Washington named
- Medical device recall Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception… Product marketed in U.S. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNew York
- Medical device recall AVS Aria Cage The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. Class IIFDA’s classOct 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Michigan, Minnesota, New Jersey, New Mexico and Oregon named
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.