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 5, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G Kits contain CONMED AirSeal Access Ports. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Indiana, Maryland, Missouri, New Jersey, Ohio and Wisconsin named
- Medical device recall IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through… Following a Chromium-based web-browser, report and displayed images may not match. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with… The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 21, 2026ClassClass IIStatusOngoingWhereArizona, California, Florida, Indiana, Louisiana, Nevada and Rhode Island
- Medical device recall Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kit labeled as: FOOT ANKLE Discrepancy in the shelf-life of a component Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses,… In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood… Class IIFDA’s classOct 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. Class IIIFDA’s classOct 14, 2026in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 14, 2026ClassClass IIIStatusOngoingWhereCalifornia
- Medical device recall VERIFY Biological/Integrator Challenge Pack Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Biological/Integrator Challenge Pack Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Dual Species Self-Contained Biological Indicator Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Dual Species Self-Contained Biological Indicator Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Biological Steam Test Pack Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Biological Steam Test Pack Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Due to a manufacturing issue (inadequate weld) for patient head positioning system. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Texas named
- Medical device recall HALYARD Laparoscopy Comprehensive Pack II Laparoscopy packs labeled as “latex free” were found to contain a latex urethral catheter Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi named
- Medical device recall Spectral CT and Spectral CT 7500 RT Software issues may affect the safety and performance of Spectral CT system(s). Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia and West Virginia named
- Medical device recall Presource Packs containing Medtronic Microstream Components: Intubation Kit Kits contain Microstream components. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Glypto Device, Glypto Cryo Machine Lack of 510(k) clearance. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Battle Bandage Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and… Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sperm Ab ELISA Potential for false negative patient results. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall DxC 500i Clinical Analyzer Modules: 1 Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxC 500 AU Clinical Chemistry Analyzers: 1 Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to… Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for… The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for… The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed… Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, Colorado, Florida, Kansas, Kentucky, Louisiana, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas and West Virginia named
- Medical device recall Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Onkos Surgical Inc Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and California and North Carolina named
- Medical device recall Onkos Surgical Inc Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and California and North Carolina named
- Medical device recall DAVINCI TRUCUSTOM BUNDLE Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall GYN LAPAROSCOPY/LAPAROTOMY Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall ADULT HEART TRAY SHANDS JACKS Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall ENDOVASCULAR PACK Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall CRANIOTOMY PACK Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall PACK OPEN HEART CFH Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall ROBOTIC PROSTATECTOMY PACK Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall LAPAROSCOPIC PROSTATECTOMY Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall PLASTICS TRAY Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall DAVINCI LAP/GYN Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall HEART PREP TRAY Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall UROLOGY MAJOR Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall MAJOR PACK; Model/Item Number (Kit): NIHB0018-11 Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall GYN LAPAROSCOPY PACK Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall ABD HYSTERECTOMY Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Nebraska and Texas named
- Medical device recall SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000 During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Alphenix INFX-8000C/B5 Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and… Class IIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Idaho named
- Medical device recall ePM Series Patient Monitor Certain monitor operator’s manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall BeneVision N1 and N-Series Patient Monitor Certain monitor operator’s manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIFDA’s classOct 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 14, 2026ClassClass IIIStatusOngoingWhereNationwide
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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