Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip… Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereIdaho and North Carolina
- Medical device recall TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography,… Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportLouisianathe one state its words name PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereLouisiana
- Medical device recall J-Plasma Precise 360, single use, disposable There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Idaho, Illinois, Maryland, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas named
- Medical device recall Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that… When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report41 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereKansas and Tennessee
- Medical device recall GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Delaware, Florida, Illinois, Indiana, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14 Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report46 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusOngoingWhereAlabama, 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, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive… Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereOklahoma
- Medical device recall MyLab Alpha, Model 7400 The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Indiana, Missouri, New Mexico, Pennsylvania, South Carolina and Texas named
- Medical device recall MyLab Gamma, Model 7410 The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Indiana, Missouri, New Mexico, Pennsylvania, South Carolina and Texas named
- Medical device recall MyLab Seven, Model 6400 The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Indiana, Missouri, New Mexico, Pennsylvania, South Carolina and Texas named
- Medical device recall Tritanium TL Steerable Inserter The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mitek Screw and Washer Depth Gauge The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall APTIO INPUT/OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall APTIO RACK INPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall APTIO CENTRIFUGE MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall APTIO 15000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall APTIO 9000 REFRIGERATED STORAGE MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall APTIO RACK OUTPUT MODULE The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall STREAMLAB CORE UNIT / LYNX WITH IOM The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall STREAMLAB - REFRIGERATED STORAGE MODULE 9000 The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall STREAMLAB - REFRIGERATED STORAGE MODULE 15000 The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall NucliSENS¿ Magnetic Extraction Reagents Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Massachusetts, Maryland, Ohio, Oregon, Texas and Washington named
- Medical device recall Surgical Handpiece Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Surgical Handpiece Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Surgical Handpiece Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Surgical Handpiece Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Micro Surgery Handpiece SGS Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Micro Surgery Handpiece SGS Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Micro Surgery Handpiece SGA Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall Micro Surgery Handpiece SGA Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois and Washington
- Medical device recall VirtuoSaph Plus Endoscopic Vessel Harvesting System The system’s IFU contains a list of generators that the have been deemed compatible. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, New York, Ohio and Texas named
- Medical device recall BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial… The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE)… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Vermont and West Virginia named
- Medical device recall BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial… The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE)… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Vermont and West Virginia named
- Medical device recall BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU… The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE)… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Vermont and West Virginia named
- Medical device recall Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively… The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on… The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used… The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used… The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Altrix¿ Precision Temperature Management System Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner… A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Utah named
- Medical device recall Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Indiana, Missouri, Montana, Nevada, Oklahoma, Oregon, Pennsylvania and Texas named
- Medical device recall 3.0mm Headless Compression Screw, Long Thread 18mm The product inside the package does not match the label. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Illinois, New Mexico, Ohio and Texas
- Medical device recall Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029,… Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CHS Custom Convenience Kit-DR Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
- Medical device recall CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10’S Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Class IIFDA’s classOct 31, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereConnecticut, Georgia, Illinois, Kentucky, Maryland, North Carolina, Oklahoma, South Carolina and Virginia
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.