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 5, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed… Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maryland, Missouri, North Carolina, New Jersey, Puerto Rico and Texas
- Medical device recall Tibial Component Fixed Hinge Small Long The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, Nebraska, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Tibial Component Metal Cased Small Long The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, Nebraska, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Femoral Shaft L=120mm The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, Nebraska, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Femoral Integral Shaft & Stem 15x27 HA Coated The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, Nebraska, New York, Ohio, Pennsylvania and Texas named
- Medical device recall DF Coated Integral Shaft & Stem 15x30x38 The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Louisiana, Maryland, Mississippi, Nebraska, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Ingenia MR-OR Possibility that a patient or user may be exposed to a very small level of touch current. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medical device recall Affinity Fusion” Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir,… Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Minnesota, North Dakota, Nevada, New York, South Dakota, Tennessee, Texas, Wisconsin and Wyoming named
- Medical device recall Zeus-P Lumbar Interbody Device Labeling error where three boxes in inventory had conflicting patient and primary labels. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereGeorgia, Michigan, Oklahoma, South Carolina, Texas and Virginia
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a… A limited number of product pouches may not have been sealed during packaging. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNo state 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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