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 LMA MADomizer Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of… Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an… Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LMA MADgic, Atomization Device with 3mL Syringe Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LMA MADett, Endotracheal tube Mucosal Atomization Device Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an… Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit,… Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ANGIODYNAMICS 4F Stiffened Micro-Introducer Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall DELFIA hFSH kit A DELFIA hFSH kit lot failed real time stability testing. Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, New York and Washington
- Medical device recall PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereIowa, Maryland, New York and Washington
- Medical device recall Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Virginia named
- Medical device recall Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile… Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws,… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws,… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes. Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws,… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Ultroid Sterile Disposable Probes Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws,… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall AbbVie PEG Kit 20 FR AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMS-651, 120” Microbore extension set with slide clamp Incorrect priming volume is printed on the device package. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a… Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned… 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 OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM 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 OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM 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 OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM 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 OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM 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 OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM 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 OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP 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 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¿ 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 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
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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