Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Computed Tomography X-ray Systems Ingenuity Core 128 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named
- Medical device recall Computed Tomography X-ray Systems Ingenuity CT scanners 5 issues. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named
- Medical device recall MiniMed NGP 640G 1.8ml (mmol/L) Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used… Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II The markings on the distal face of the instruments are mis-oriented by 180¿. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medical device recall Paragon Laboratory Management For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, West Virginia and Wyoming named
- Medical device recall IPS Empress Universal Glaze Spray 270 mL Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereIowa, Indiana, Pennsylvania and South Carolina
- Medical device recall Invivo Expression MRI Patient Monitoring System. The device’s labeling inaccurately indicates Endotracheal as a body temperature application site. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall OxiMax N-65 Handheld Pulse Oximeter Potential missing segments on the display that can result in misinterpretation of data. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OxiMax N-560 Pulse Oximeter Potential missing segments on the display that can result in misinterpretation of data. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prism Medical P-440 Portable Ceiling Lift There is a potential the sling loops may not stay attached to the carry bar hooks. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prism Medical P-600 Portable Ceiling Lift There is a potential the sling loops may not stay attached to the carry bar hooks. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fabius MRI Anesthesia Machine the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary… The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Kentucky, Maryland, Mississippi, New Jersey, New York, Utah, Vermont, Washington and Wyoming named
- Medical device recall Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Acorn, 7MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Drum, Side Cut Only G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Barrel G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Barrel G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Extra Coarse Diamond Ball G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Ball G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - Fluted Drum, Side Cut Only G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM x 11.3MM Fluted Barrel G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 6MM x 11.3MM Fluted Barrel G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 7MM Fluted Acorn G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 7MM Extra Coarse Diamond Ball G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 8MM x 12.5MM Fluted Barrel G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 4MM Fluted Ball, Extends 27MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM Fluted Ball, Extends 27MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH -4MM Carbide Fluted Ball, Extends 27MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
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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