Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall OMNI Hip System Stems missing porous coating on the device. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereIllinois and Oklahoma
- Medical device recall The ICS CHARTR EP 200 There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, 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, Washington, Wisconsin and West Virginia
- Medical device recall Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01 The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereGeorgia, Louisiana, Massachusetts, North Carolina, New York, South Carolina and Texas
- Medical device recall Semi-Rigid Suction Canister, 3000cc Potential for the Semi-Rigid canister lid to fragment during use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 30, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall ApexPro Telemetry Server System May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 30, 2019ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Patient Data Manager The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1,… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sterile Co-Flex NL 3” - Product Usage: Single Use secondary wound dressing or compression wrap. Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Sterile Co-Flex NL 4” - Product Usage: Single Use secondary wound dressing or compression wrap Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Sterile Co-Flex LF2 3” - Product Usage: Single Use secondary wound dressing or compression wrap Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Sterile Co-Flex LF2 4” - Product Usage: Single Use secondary wound dressing or compression wrap Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Sterile Co-Flex Med 3” - Product Usage: Single Use secondary wound dressing or compression wrap Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Sterile Co-Flex Med 4” - Product Usage: Single Use secondary wound dressing or compression wrap Incomplete packaging seal of sterile product Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Minnesota, Missouri, Nebraska, New York, Ohio, Rhode Island, South Dakota, Texas, Utah and Virginia named
- Medical device recall Torrent Suite Dx Software Version (IUO) 5.2 Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, North Carolina, New Jersey, New Mexico, New York, Oregon, Texas, Virginia and Washington
- Medical device recall Torrent Suite Dx Software Version (IUO) 5.4 Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, North Carolina, New Jersey, New Mexico, New York, Oregon, Texas, Virginia and Washington
- Medical device recall Torrent Suite Dx Software Version 5.6.4 Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, North Carolina, New Jersey, New Mexico, New York, Oregon, Texas, Virginia and Washington
- Medical device recall Torrent Suite Dx Software Version 5.8 Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Massachusetts, Maryland, North Carolina, New Jersey, New Mexico, New York, Oregon, Texas, Virginia and Washington
- Medical device recall GRIPPER Needles Potential for certain GRIPPER Needles to contain an occluded or blocked needle. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall GRIPPER Needles Potential for certain GRIPPER Needles to contain an occluded or blocked needle. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Irrisept Wound Debridement and Cleansing System. 12 units per case. Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian,… Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Separation of front and rear barrels upon activation of the safety feature that retracts the needle Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000 Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with… The canister neck bushing may become loose and separate from the body of the canister during use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use… The canister neck bushing may become loose and separate from the body of the canister during use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with… The canister neck bushing may become loose and separate from the body of the canister during use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use… The canister neck bushing may become loose and separate from the body of the canister during use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report28 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Beckman Coulter Lipase NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Beckman Coulter Uric Acid NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Georgia, Illinois, Massachusetts, Minnesota, North Carolina, New Jersey, Oklahoma, Oregon and Washington named
- Medical device recall Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X,… Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X,… Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cerelink ICP Monitor There is a potential for a progressive decline in observed ICP readings of the monitor during use. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement Report11 statesnamed in where it went PublishedOct 23, 2019ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Indiana, New York, Oklahoma, Pennsylvania, Texas, Wisconsin and West Virginia
- Medical device recall OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm-… Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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