Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: Forza” Ti Spacer System Product Name: Forza” Ti Spacer System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: CONSTRUX” Mini Ti Spacer System Product Name: CONSTRUX” Mini Ti Spacer System Labeling contains claims that are not consistently present. Class IIIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedDec 17, 2025ClassClass IIIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall ChemoPlus gowns Affected gowns have the incorrect expiration date on the product packaging. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75” x 3”, 30/Box, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Quick Strip Plastic Sterile Adhesive Bandages, 0.75” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Quick Strip Plastic Sterile Adhesive Bandages, 1” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Fur Friends Plastic Sterile Adhesive Bandages, 0.75” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Quick Strip Fabric Sterile Adhesive Bandages, 0.75” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Quick Strip Fabric Sterile Adhesive Bandages, 1” x 3”, Medline Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportGuamthe one state its words name PublishedDec 17, 2025ClassClass IIStatusOngoingWhereGuam
- Medical device recall Bard InLay Optima Size: 6 Fr Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin named
- Medical device recall BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin named
- Medical device recall BD InLay Optima Ureteral Stent Kit Size: 6 Fr Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin named
- Medical device recall BD InLay Optima Ureteral Stent Kit Size: 8 Fr Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin named
- Medical device recall AMSCO 7052HP Washer/Disinfector Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New Hampshire, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall AMSCO 7053HP Washer/Disinfector Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, North Carolina, New Hampshire, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall DEXLOCK Achilles Repair Implant Kits, MAKT4520 There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Montana, North Carolina, New Jersey, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall Hemodialysis System, Surdial DX Screw may loosen or fallout of Hemodialysis system Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Iowa, Illinois, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas and West Virginia named
- Medical device recall Cardiosave Hybrid The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker MV3 bariatric bed Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity,… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Arise 1000EX mattress Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity,… Class IIFDA’s classDec 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual… Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 10, 2025ClassClass IStatusOngoingWhereNationwide, and Illinois, Maryland, Michigan, Oklahoma, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall InSure ONE Fecal Immunochemical Test InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and West Virginia named
- Medical device recall Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators… There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alcohol (ALC) Test Saliva Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blood Type Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Candida Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Chlamydia Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall D-Dimer Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Diabetes HbA1c Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Illegally Marketed Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Drug Test Small Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Epstein-Barr Virus (EBV VCA & EBNA IgG) Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fecal Occult Blood Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Female Fertility Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Gonorrhea test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall H pylori (Peptic ulcer) Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Herpes (HSV-1 & HSV-2) Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HPV Antigen Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Iron Deficiency Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lyme Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Menopause (FSH) 2 Tests Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MPOX Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mycoplasma test, IgG and IgM Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ovulation Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Parasite Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pregnancy Test Distribution without premarket approval/clearance. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass 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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