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 SafeStep Huber Needle 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 with Y Injection Site and Medegen Needleless Injection Cap 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 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 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 ANAX 5.5 Poly-Reduction Screw 6.0X50MM 6.0x50mm poly-reduction screws were laser etched 6.0x45 Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportArizonathe one state its words name PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereArizona
- Medical device recall Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting… During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX… The needle surface deteriorated due to unexpected electrolysis during procedure. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Nuvasive NVM5 EMG Module The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Iowa, Illinois and Wisconsin named
- Medical device recall TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. 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 MEVION S250 Proton Radiation Treatment System The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Missouri, New Jersey, Ohio and Oklahoma
- Medical device recall Sysmex PS-10 Sample Preparation System Insufficient amount of antibody without an error message or alarm Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Florida, Illinois, Maryland and Washington named
- Medical device recall syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 If the user modifies for any reason (e.g. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas and Wisconsin named
- Medical device recall IntelliVue G7m Anesthesia Gas Module The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more… Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN:… Insertion difficulty of the probes. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntelliVue MX800 patient monitor Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Massachusetts, New York and Utah
- Medical device recall IntelliVue MX700 patient monitor Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. Class IIFDA’s classJul 29, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Hawaii, Massachusetts, New York and Utah
- Medical device recall MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is… Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Michigan, North Carolina, Pennsylvania, Texas and Washington named
- Medical device recall MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the… Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Michigan, North Carolina, Pennsylvania, Texas and Washington named
- Medical device recall MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the… Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Michigan, North Carolina, Pennsylvania, Texas and Washington named
- Medical device recall POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C… Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Class IIIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2020ClassClass IIIStatusTerminatedWhereNationwide, and New York named
- Medical device recall MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This… When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for… Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated… The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Indiana, North Carolina, Nevada and South Carolina named
- Medical device recall BodyGuard BodySet Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Filter Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Vermont, Washington, Wisconsin and Wyoming
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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