Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Product Name: Disposable Triple Lumen Sphincterotome Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Product Name: Single Use 3-Lumen Sphincterotome V Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Devices which did not undergo thermoforming could deform and lose performance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Product Name: Nasal Jejunal Feeding Tube Nasal feeding tube packaged without the nasal transfer tube component. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall FDR Visionary Suite It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Connecticut, Florida, Illinois, New Hampshire, Ohio and Wisconsin named
- Medical device recall Bubble Sensor for 3/8” x 3/32” tubing Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse G pTau 217 Plasma Calibrators Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse pTau 217 Plasma Controls Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Product Name: Lumipulse ¿-Amyloid Plasma Controls Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, Texas and Washington named
- Medical device recall Brand Name: Molift Product Name: Molift Mover 205 A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: Molift Product Name: Molift Mover 300 A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Broselow Product Name: BROSELOW” FILLED BROSELOW ORGANIZER Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity,… Due to a manufacturing issue and electrical grounding of systems. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc Incorrect expiration date Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wyoming named
- Medical device recall Fixone Hybrid Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Fixone Biocomposite Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Genesis Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Genesis Dual Thread Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Genesis Knotless Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Genesis Push-In Suture Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall AlternatiV+ Max Knotless Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall AlternatiV+ Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Puerto Rico named
- Medical device recall Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia and Wisconsin named
- Medical device recall Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia and Wisconsin named
- Medical device recall Alphenix INFX-8000C, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alphenix INFX-8000F, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alphenix INFX-8000H, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alphenix INFX-8000V, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT Potential exposure of rodents and rodent activity in the distribution center. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN… Potential exposure of rodents and rodent activity in the distribution center. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT,… Potential exposure of rodents and rodent activity in the distribution center. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT Potential exposure of rodents and rodent activity in the distribution center. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall PREGNANCY TEST 24CT Potential exposure of rodents and rodent activity in the distribution center. Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall Conductivity Standard Solution due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during… Class IIFDA’s classFeb 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2026ClassClass IIStatusOngoingWhereNationwide
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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