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 135” (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer,… 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 140” (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2… 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 84” Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 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 84” (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer,… 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 85” (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 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 99” (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The… 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 99” (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, 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 120” (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The… 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 121” (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-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 132” (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, 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 175” (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks… 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 140” (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer,… 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 100” (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap,… 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 125” (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, 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 164” (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks… 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 105” (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating… 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, MicroClave¿ Clear, Rotating Luer, Approx… 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 80” (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap,… 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 162” Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks… 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 128” (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow)… 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” (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The… 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) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap,… 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 100” (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter… 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 99” (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, 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 99” (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The… 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 98” (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1… 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 132” (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer… 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 134” (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer… 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 143” (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way… 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 159” (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer… 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 115” (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced… 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 139” (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate,… 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 125” (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock… 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 98” (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer,… 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 126” (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating… 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 107” (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks,… 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 117” (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks,… 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 116” (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, 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 120” (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, 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 Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. Recall is due to a design weakness of the power insert module. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report22 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas and Utah
- Medical device recall Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient… The spreader bar can detach from the scale attachment under certain conditions. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, New York and Washington named
- Medical device recall Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient… The spreader bar can detach from the scale attachment under certain conditions. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Iowa, Illinois, Kentucky, Minnesota, New York and Washington named
- Medical device recall Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded… Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius… Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Stem Implant, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Stem Implant, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lateral Assembly, Radial Stem Implant, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lat Assembly, Rad Stem Implant,Collar 6mm, Size1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass 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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