Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical… IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportVirginiathe one state its words name PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall ClearPro T-Piece Closed Suction Catheter There are reports of the suction catheter coming apart from the device assembly during use. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Mississippi, Nevada, New York, Ohio, Pennsylvania and Texas named
- Medical device recall ClearPro Trach T-Piece Closed Suction Catheter There are reports of the suction catheter coming apart from the device assembly during use. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Mississippi, Nevada, New York, Ohio, Pennsylvania and Texas named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Rusch Greenlite Breaking at the point of a welded joint Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Sterile Low Profile Screw, Titanium, 6.7 x 65mm Screws provided in packaging are 5mm shorter than intended Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Progressa Bed Affected beds may have screws installed that do not meet material tensile strength requirements. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Indiana, Kentucky, Maryland, Maine, Michigan, Missouri, North Carolina, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Centrella Smart+ Bed Affected beds may have screws installed that do not meet material tensile strength requirements. Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Indiana, Kentucky, Maryland, Maine, Michigan, Missouri, North Carolina, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and… One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have… Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE” 5.5/6.0 Spine System is intended for… Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device Class IIFDA’s classAug 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 5, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kentucky, Michigan, Missouri, North Carolina, New York, Ohio and Texas named
- Medical device recall Expansion Control Overlay QC inspection observed that a portion of the lot may have been contaminated with blood. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Computed Tomography X-ray System Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 29, 2020ClassClass IIStatusOngoingWhereTexas
- Medical device recall LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. Class IIIFDA’s classJul 29, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 29, 2020ClassClass IIIStatusTerminatedWhereKansas, Minnesota, Missouri, Utah and Washington
- Medical device recall LoFric Origo, Nelaton, 16in, FR10 urinary catheters Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo” urethral catheters due to a potential defect which may be present in the catheter s distal… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas and Virginia
- Medical device recall LoFric Origo, Tiemann, 16in, FR12 urinary catheters Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo” urethral catheters due to a potential defect which may be present in the catheters distal… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas and Virginia
- Medical device recall LoFric Origo, Tiemann, 16in, FR14 urinary catheters Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo” urethral catheters due to a potential defect which may be present in the catheters distal… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas and Virginia
- Medical device recall Thora-Para 5 Fr Non-Valved Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T-Centesis 6 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T-Centesis 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Thora-Para 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T 8 Fr Thora-Para Tray With 8 Fr The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Thora-Para 5 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T 5 Fr Thora-Para Tray With 5 Fr The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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
- Medical device recall PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PowerLoc MAX Power Injectable Infusion Port Access Kit Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SafeStep Huber Needle Set AllPoints Port Access System Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SafeStep Huber Needle Set myPICK Port Access Kit Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SafeStep Huber Needle Set Port Access Kit Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNo state 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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