Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Check-Flo Performer Introducer, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Check-Flo Performer Introducer Set, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Check-Flo Hemostasis Assembly, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Flexor Radial Access Set, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Micropuncture Check-Flo Performer Introducer Set, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall TriForce Peripheral Crossing Set, Individual product is Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report46 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall BD AffirM VPIII Microbial Identification Test BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini… Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. Class IIFDA’s classMar 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, North Carolina and Texas named
- Medical device recall McKesson Radiology 12.2 - Picture Archive Communication System (PACS) Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a… Class IIFDA’s classMar 8, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 8, 2017ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Hawaii, Kentucky, Maryland, Michigan, Mississippi, New Hampshire, Ohio, Pennsylvania, Tennessee, Texas and Vermont
- Medical device recall Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use… Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, California, Kansas, Kentucky, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New Jersey, New York, Oklahoma, South Carolina and Texas
- Medical device recall AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes. Expired expiration dates are listed on the pouches. Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Maine, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes. Expired expiration dates are listed on the pouches. Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Maine, Minnesota, Missouri, North Carolina, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Washington and Wisconsin
- Medical device recall Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ETEST XM256 (Cefuroxime), Foam: 506958-506918 Potential performance issues. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report37 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for… The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Colorado named
- Medical device recall Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the… There have been complaints for peel away sheaths flaring Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Efficia CMS200 Central Monitoring System The monitor may not alarm appropriately for a pediatric or neonatal patient. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DIAMONDBACK 360 Peripheral 1.50 Classic CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Mississippi, South Carolina and Texas named
- Medical device recall Influenza Transport Swab Packages, Reference #20171, One Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Indiana, Kentucky, Montana, Ohio, Pennsylvania and Texas named
- Medical device recall Titan” Stabilizer Attachment and Titan TM 360 Stabilizer Attachment Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan” Stabilizers and Titan” 360 Stabilizers because the Suction Tubing… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar Product sterility compromised due to breach of sterile barrier Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 1, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile Sterility of syringe product could not be assured. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusOngoingWhereIdaho and Oregon
- Medical device recall The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Hidrex USA DP450 The device was reclassified from a class III device to a class II device and there are new documentation requirements. Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
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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