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 Medtronic, Evera Implantable Cardioverter Defibrillators: Product 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico and Texas named
- Medical device recall Brilliance 64 CT After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brilliance CT Big Bore Oncology After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brilliance BigBore Radiology CT After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brilliance 16 After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brilliance CT 16 Power After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenuity Core After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenuity Core128 After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a “pop-up screen” that was prematurely released. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinite F50 instrument The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall SUNRISE instrument The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Tecan Infinite 200 The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that… The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate… The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates The batteries have the potential to overheating, melt or char. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Florida, Georgia, Hawaii, Kentucky, Massachusetts, Maryland, North Carolina, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and… Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters,… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TrueBeam¿ Radiotherapy Delivery System and EDGE” Radiotherapy Delivery System, K140528 Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters,… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall OraQuick Ebola Rapid Antigen Test Failed stability testing at 8 months. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 24, 2016in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedAug 24, 2016ClassClass IStatusTerminatedWhereGeorgia
- Medical device recall Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Gold-Tite Square Uniscrew Item: UNISG Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Extended Range Males 4pk Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Extra Light Angled Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Extra Light Retention Males 4pk Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Light Retention Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Replacement Housing Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Replacement Housing Kit Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Locator Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands 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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