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 BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING 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 TITANIUM RETAINING SCREW 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 VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP… Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Florida, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are… Device could cause a patient overpressure situation without any visual or auditory indication or warning Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida and Massachusetts
- Medical device recall Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8470-009-040 4.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery)… Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall BD SurePathTM Preservative Collection Vials BD has confirmed that a portion of BD SurePath” collection vials associated with specific production lots may contain caps that are cracked which can lead to… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merge OrthoCase software Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Massachusetts, Maryland, Minnesota, Montana, Nebraska, New Jersey, Nevada, New York, Pennsylvania, South Carolina, Washington and Wisconsin
- Medical device recall OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw Labeled as a 48mm Cortical Screw but measuring at 50mm Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereArizona, Florida, Georgia, Missouri, North Carolina, New York and Texas
- Medical device recall GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH,… A review of packaging revealed the seal integrity of the pouch may be compromised. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-Wire 1.4mm x 12in Non-Threaded The rods are packaged in packages with unacceptable seals. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Dual Stylet Needle The rods are packaged in packages with unacceptable seals. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Savannah-T Straight Rod, 200mm The rods are packaged in packages with unacceptable seals. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens… Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2,… Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Black Widow Plate 19mm Plate There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Louisiana and Texas named
- Medical device recall Black Widow 6.6mm x 20mm Screw There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Louisiana and Texas named
- Medical device recall Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA… Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Clearify Visualization System Product sterility is compromised due to breach of the sterile barrier Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Best Practices kits containing certain production lots of Clearify Visualization System Product sterility is compromised due to breach of the sterile barrier Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optimus Fixed Awl Complaints that the tip of the awl broke after impaction during surgery. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, Missouri and Texas
- Medical device recall ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNorth Carolina, New York and Washington
- Medical device recall Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents… Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts, New Jersey and Pennsylvania
- Medical device recall CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE Covidien issued a labeling update for the Covidien Devon Light Gloves. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medical device recall BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE Covidien issued a labeling update for the Covidien Devon Light Gloves. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medical device recall SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE Covidien issued a labeling update for the Covidien Devon Light Gloves. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medical device recall EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of… Unique Device Identifier (UDI) is missing from outer kit box label. Class IIIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIIStatusTerminatedWhereAlaska and Massachusetts
- Medical device recall Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter 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 AQURE System Software Version 2.2.0 Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereMichigan and New York
- Medical device recall Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. Class IIFDA’s classDec 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall Carry bar which is an accessory to a lift used for patients in hospitals and other facilities The black plastic puck on the carry bar is breaking resulting in potential for patient harm. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Cardio software If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Cardio software Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery Edits to Particle field definition parameters may not be saved when the field definition window is saved. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Missouri, New Jersey, Ohio, Oklahoma, Tennessee, Texas and Virginia named
- Medical device recall Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat… GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America “DUOMAT 3” Head/Foot motor… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum… Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through… Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Louisiana, Minnesota, Mississippi, North Carolina, Nevada, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall CyberKnife Robotic Radiosurgery System using software version 10.6 Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Kentucky, Minnesota, Montana, New Jersey, New York, Pennsylvania, South Carolina, Washington and Wisconsin
- Medical device recall BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD¿ Piston Syringe, 60cc Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARDIA¿ 60cc Piston Irrigation Syringe, Sterile Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility. Class IIFDA’s classDec 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2016ClassClass IIStatusTerminatedWhereNationwide
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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