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 Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) UMC DR Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) NASAL PACK Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See DocMan Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See DocMan Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See DocMan Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline custom medical procedure kits labeled as: 1) CRANI Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SUC-4300S, Rigid Intracardiac Sucker Fluted Tip Incomplete or partial pouch seals, which may result in a breach in the sterility. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJan 8, 2025ClassClass IIStatusOngoingWhereIllinois
- Medical device recall 3M Unitek Transbond Plus Self-Etching Primer Due to an increase of complaints for bracket bond failures and skin irritation or blistering. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 8, 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 Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic… Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereAlabama, Florida, Illinois, Pennsylvania and South Carolina
- Medical device recall Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid… Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereAlabama, Florida, Illinois, Pennsylvania and South Carolina
- Medical device recall Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used… Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereAlabama, Florida, Illinois, Pennsylvania and South Carolina
- Medical device recall StatStrip Glucose Hospital Meter System A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution’s… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall StatStrip Glucose Ketone Hospital Meter System A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution’s data… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall StatStrip Glucose Ketone (mmol/L) Hospital Meter System A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution’s data… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportAlaskathe one state its words name PublishedJan 1, 2025ClassClass IIStatusOngoingWhereAlaska
- Medical device recall Monitoring Service Application (MSA) Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall MAJOR NEURO PACK-LF Convenience kit Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FESS-MB PACK-LF Convenience kit Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DIEP FLAP Convenience kit Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1 Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SEPTOPLASTY PACK Convenient kit Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KIT,SPINE LH Convenience kit Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Access hsTnI Reagent Beckman Coulter, Inc. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 20/30 INDEFLATOR Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 20/30 Priority Pack Accessory Kit/.096 RHV Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 20/30 Priority Pack Accessory Kit w/Copilot Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 20/30 Priority Pack Kit/.115 RHV Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report39 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 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.”
Your shortlist0 of 4
Add one more to compare.