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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall GE Healthcare Infinia I Hawkeye 1 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Infinia II Hawkeye 4 GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Varicam Millennium VG Discovery VH GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system… Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereIllinois, New York and Ohio
- Medical device recall Medtronic NanoCross Elite PTA catheter There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BD Pyxis MedStation ES (Med ES Main) Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Louisiana, North Carolina and New York named
- Medical device recall Panther Fusion GBS Assay Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereArkansas, California, Connecticut, Florida, Indiana, Kansas, Louisiana, Massachusetts, Maine, Michigan, North Carolina, New Jersey, Nevada, New York, Puerto Rico, Texas, Utah, Vermont, Washington and West Virginia
- Medical device recall Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951 Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1 ) ANEURYSM PACK Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 0 ) DESCRIPTION Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) CRANIOTOMY PACK Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Portrait Core Services, a set of software services that enable the communication and interaction of the… There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio and Texas named
- Medical device recall OsteoCove Putty, 1.25cc Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Maryland, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oklahoma and Texas named
- Medical device recall Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Idaho, Illinois, Kentucky, New Jersey, New York, Ohio and Texas
- Medical device recall DRG:HYBRiD-XL Insulin The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall 8MM, Tenaculum Forceps Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 8MM, Small Graptor Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2025ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE” BUCK EAR CUR BL STR#0STRLCS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25” CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13”STER25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5”CS25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE” CURETTE EXCAVATOR STRL CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75” STER CS5 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5” C10 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8” CVD CS/25,Model Number… Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8”CS25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2” CVD CASE/50,Model Number… Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number… Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 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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