Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LipiFlow thermal Pulsation System, consisting of Console and Activator Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlaska, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from… Contents of the package do not match the product labeling. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan and New Jersey named
- Medical device recall Sagittal Blade 18.0X0.97X90MM Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product’s packaging. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Idaho, Maryland, North Dakota, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable)… The device has the potential to be packaged in the wrong product box. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CADstream software Product Usage: CADstream is an image processing system designed to assist in the… Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kentucky, Michigan, Mississippi, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kentucky, Michigan, Mississippi, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kentucky, Michigan, Mississippi, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935 Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Indiana, Kentucky, Michigan, Mississippi, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity… According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Calix P PEEK Lumbar System, PLIF Rasp The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Puerto Rico, Texas and West Virginia
- Medical device recall Calix P PEEK Lumbar System, PLIF Trial The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Puerto Rico, Texas and West Virginia
- Medical device recall Calix T PEEK Lumbar System, TLIF Rasp The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Puerto Rico, Texas and West Virginia
- Medical device recall Calix T PEEK Lumbar System, TLIF Trial The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, Nevada, New York, Pennsylvania, Puerto Rico, Texas and West Virginia
- Medical device recall CD79b PE (ASR) CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Minnesota, Ohio and Texas named
- Medical device recall CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CORE¿ Trumpet Handpiece only The packaging seal may contain a crease. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Agee-WristJack¿ Fracture Reduction System A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CADstream software The software was not presenting the PURE filter user interface message on DICOM transfer studies. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report50 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Abdominoplasty Tray, there are two Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Anterior Cervical Fusion Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Augmentation Mammoplasty Tray, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Extended Pack, kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Face Kit, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Setup Pack, kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basic Tray, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Bayview Abdominoplasty Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Bayview Breast Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Bleph Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Body Contour Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Breast Augmentation Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Breast Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Brow Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall C-Birth Pack, Kit The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming 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.”
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