Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall PROXIMALE - 28 cm ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 191 cm (75”) Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 40 cm (16”) Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall PROXIMALE - 18 cm ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 38 cm (15”) Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 61 cm (24”) Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter,… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve,… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 11” Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 10” Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave… ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall 6” Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Massachusetts, North Carolina, Ohio, Texas, Virginia and Washington
- Medical device recall HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece… The packaging may not be sealed. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Wisconsin and West Virginia named
- Medical device recall HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece… The packaging may not be sealed. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Wisconsin and West Virginia named
- Medical device recall ARCOS Modular Revision Hip System Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Missouri, New York and Virginia
- Medical device recall ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Illinois, Missouri, New York and Virginia
- Medical device recall NICO Shepherd’ s Hook - Greenberg, sterile Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and… Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable… Mix-up between adult and pediatrics PD catheter. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Florida, Kentucky, Massachusetts, Missouri, North Carolina, New York, Ohio, Pennsylvania and Utah named
- Medical device recall Sorin Platinium CRT-D 1711 DF-1, Sterile EO Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois, Louisiana, Michigan, Mississippi, New Jersey, Oklahoma and Pennsylvania
- Medical device recall Sorin Platinium CRT-D 1741 DF-4, Sterile EO Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, Illinois, Louisiana, Michigan, Mississippi, New Jersey, Oklahoma and Pennsylvania
- Medical device recall Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Distribution of unapproved product labeling Class IIIFDA’s classAug 22, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 22, 2018ClassClass IIIStatusTerminatedWhereFlorida, Massachusetts, Montana, Oklahoma, Oregon and Wisconsin
- Medical device recall Powder Free Vinyl Exam Gloves The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Iowa, Louisiana, Oklahoma, Texas, Utah and Virginia named
- Medical device recall Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive Device could not meet the requirements for systolic pressure Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusCompletedWhereNationwide
- Medical device recall O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. There is a potential for imaging artifact to mimic calcifications on patient’s mammograms Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography. There is a potential for imaging artifact to mimic calcifications on patient’s mammograms Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in… There is a potential for imaging artifact to mimic calcifications on patient’s mammograms Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The da Vinci Xi Surgical System (IS4000) An Endoscope Controller has been improperly calibrated during manufacturing. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 22, 2018ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Salivary Estradiol ELISA Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall AirLife Resuscitation Device, Adult labeled as the following: a An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement Report28 statesnamed in where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Puerto Rico, South Dakota, Texas, Virginia and Washington
- Medical device recall AirLife Resuscitation Device, Pediatric labeled as the following: a An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement Report28 statesnamed in where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Puerto Rico, South Dakota, Texas, Virginia and Washington
- Medical device recall AmniSure ROM Test under the following labels: 1) Potential for control line not appearing on the test strip FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal… This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereColorado and Texas
- Medical device recall Think Surgical Cutter, Flat, ¿6.2mm x 144mm There is a potential for the cutter head to detach from the cutter shaft. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNew Jersey, New York, Ohio and Texas
- Medical device recall 119” Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 185 cm (73”) Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 108” 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext,… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 168 cm (66”) 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 32” (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 32” (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 218 cm (86”) Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector,… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile,… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 112” Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 137” (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext,… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 94” (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 88” (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 147” (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue,… Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia 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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