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 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall American Contract System Convenience Kit, CV B PACK The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa and Ohio named
- Medical device recall American Contract System Convenience Kits, CV B PACK The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa and Ohio named
- Medical device recall American Contract System Convenience Kit, D & C PACK The Convenience Kits contain Medline’s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa and Ohio named
- Medical device recall Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Software issue may cause measurements to be displayed inaccurately. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Kentucky, Nebraska and Washington named
- Medical device recall Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Halyard TOTAL JOINT Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Mississippi and Texas named
- Medical device recall Midmark IQecg Digital ECG A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Midmark Digital ECG HD+12, HD+15 A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used… Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Minnesota, North Carolina, Nevada, Ohio, Pennsylvania and Texas named
- Medical device recall Structur 2 SC Temporary Resin Cartridge Refill 75Gm Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT… Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: LTP CDS-LF, Medline kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) C-SECTION, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) LAVH, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit Kits contain a potentially contaminated component which were recalled by the manufacturer Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, Montana, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas and Wisconsin named
- Medical device recall FUJIFILM Synapse PACS software v7.4.310 Software issue may cause the ruler measurement to be inaccurate. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Kansas, New York, Ohio, Oregon and Virginia named
- Medical device recall healthmark ProChek-II Test manufactured with an expired ingredient which may present as either a false negative or positive. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall healthmark ProChek-W Protein Test for Robotic Arms Test manufactured with an expired ingredient which may present as either a false negative or positive. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORT300, operating room table, ORT300 Modular Table Main Unit Assy The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Kansas named
- Medical device recall PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereMichigan and New York
- Medical device recall PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereMichigan and New York
- Medical device recall PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereMichigan and New York
- Medical device recall FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereMichigan and New York
- Medical device recall BD Needle Kit for Powered Driver 15mm x 15Ga After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2026in FDA’s Enforcement Report32 statesnamed in where it went PublishedAug 26, 2026ClassClass IStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia
- Medical device recall Lago X Momentary absence of On-Screen “X-Ray On” banner during run readiness check. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ami HTX Momentary absence of On-Screen “X-Ray On” banner during run readiness check. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM… The system’s 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Hamilton Microlab STAR Liquid Handler Software issue that can cause an increase in spontaneous software closures. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts and North Carolina named
- Medical device recall One-Piece Guedel Airway, size 00, ISO 5.0, Blue Devices could potentially be occluded or partially occluded. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Indiana, Michigan, Ohio and Virginia named
- Medical device recall One-Piece Guedel Airway, size 000, ISO 3.5, Light Green Devices could potentially be occluded or partially occluded. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Indiana, Michigan, Ohio and Virginia named
- Medical device recall Dentsply Sirona Capsule Mixer Potential for electrical discharge from unit when unplugged. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement Report48 statesnamed in where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, 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, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Cardiac Workstation 5000 Device will intermittently provide inaccurate data related to native heart rate. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 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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