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 Renuvion/ J-Plasma Precise Handpiece Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Oryx Cervical Screw Caddy Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California and Louisiana named
- Medical device recall Frames Direct Prescription Spectacle Lenses included in the frame brands The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx… Damaged ESD bags used for storing components in Processor PCA Replacement Kits Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and New York and Oklahoma named
- Medical device recall BD Posiflush SF Saline Flush Syringe (US This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Prismaflex Control Unit Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medical device recall DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System,… Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product’s shelf-life is two (2) years, but the expiration date printed… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Kentucky, Pennsylvania, Texas and Utah named
- Medical device recall DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System,… Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product’s shelf-life is two (2) years, but the expiration date printed… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Kentucky, Pennsylvania, Texas and Utah named
- Medical device recall TorFlex Transseptal Guiding Sheath There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall NRG RF Transseptal Kit There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall The Optilite Clinical Chemistry Analyzer A software issue that may affect the analyzer’s result accuracy. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, North Carolina, Nebraska, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Kiwi Complete Vacuum Delivery System There is a potential for loss of vacuum or failure to generate vacuum when using the firm’s fetal vacuum delivery system. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA Possible mis-labeling of the device with incorrect serial number labels which may result in a patient’s misdiagnosis. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, New York, Pennsylvania and Texas named
- Medical device recall Dako Autostainer instruments: Autostainer Link 48 The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD MYPICC KIT 5F Dual-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 5F Triple-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 4F Single-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 5F Dual-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 5F Triple-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 3F Single-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 4F Dual-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall BARD MYPICC KIT 5F Dual-Lumen The kits contain surgical gowns which were subject to a recall by the supplier. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereIndiana, Missouri, Ohio and Texas
- Medical device recall NelDerm Hydrogel Dressing (Dressing: 6 x 6 Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusOngoingWhereCalifornia, North Carolina and Puerto Rico
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Virginia
- Medical device recall Oxymetry Cable, Rxonly Intermittent communication due to inconsistent crimping of connectors onto cables. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Indiana and Missouri named
- Medical device recall EMPOWR Acetabular System, Non-Sterile The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 20, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Indiana, Minnesota, South Carolina, Texas and Virginia named
- Medical device recall VITROS Chemistry Products CKMB Slides, Creatine Kinase MB The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products CKMB Slides, Creatine Kinase MB The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and… When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Michigan named
- Medical device recall Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and… When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or… Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and Maryland and Michigan named
- Medical device recall CuattroDR System Software There is a potential that an image from a previous patient study to show up in a later patient study. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereArkansas, Michigan, North Carolina, New Jersey and South Carolina
- Medical device recall Stryker Power-PRO TL cot-powered ambulance cot Ambulance Cots may not meet crash test standard BS EN 1789 Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arterial Line Kit 20ga X 3” Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. Class IIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 20, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, North Dakota, South Carolina, Texas and Virginia named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.