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 Cardiac Workstation 7000 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
- Medical device recall Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing 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 Arrow-LOK Implant Implant did not undergo required gamma radiation dose audit. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Hawaii, New York, Tennessee, Texas and Vermont named
- Medical device recall TD Navio Midi Speech Generating Device Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TD Navio Maxi Speech Generating Device Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OverStitch Suture Cinch, 1pk Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Suture Cinch Long 1pk Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GETINGE Y SENSOR Module, SERVO-U, SERVO-N The module did not undergo electrical safety tests and functional tests during production. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Minnesota and New York named
- Medical device recall Halyard LAVH PACK The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, New Jersey and New York named
- Medical device recall Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085 Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, New Jersey and New York named
- Medical device recall Paragonix Technologies Inc Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Blanketrol II Overheating of the 115V CPU board may cause the device to shut down. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Innercool Coolblue Console Overheating of the 115V CPU board may cause the device to shut down. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Blanketrol III Overheating of the 115V CPU board may cause the device to shut down. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Custom Made Device Implant 6123 Navicular Cage Small Right Rev A Device was recalled due to an elevated oxygen level in excess of the allowable limit. Class IIIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIIStatusOngoingWhereNationwide, and Montana named
- Medical device recall Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A Device was recalled due to an elevated oxygen level in excess of the allowable limit. Class IIIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIIStatusOngoingWhereNationwide, and Montana named
- Medical device recall Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module… a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Syva EMIT 2000 Quinidine Assay Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Beckman Coulter, Emit 2000 Quinidine Assay Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS Potential for arterial sheath tip separation or partial tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS Potential for arterial sheath tip separation or partial tip separation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall BMC/REACTHEALTH Luna G3 APAP Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2026in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 26, 2026ClassClass IStatusOngoingWhereFlorida
- Medical device recall MiniMed 640G Insulin Pump Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result… 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 MiniMed 670G Insulin Pump Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result… 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 MiniMed 780G Insulin Pump Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result… 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 Fort Defiance Industries (FDI), Automated Field Steam Sterilizer The Automated Field Steam Sterilizer’s water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could… Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Maryland, New Jersey, Tennessee and Virginia named
- Medical device recall Esteem Body Soft Convex Urostomy Pouch Urostomy Pouches may leak from cap during use. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400 The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereIowa, Minnesota and Missouri
- Medical device recall American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988 The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 26, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 26, 2026ClassClass IIStatusOngoingWhereIowa, Minnesota and Missouri
- Medical device recall Baxter Duo-Vent Solution Set and Male Luer Lock Adapter Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereCalifornia, Florida, North Carolina, Oklahoma, Texas and Virginia
- Medical device recall BOBBY Balloon Guide Catheter Due to an increase rate of balloon pinhole defects. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Mexico, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5 Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall GORE VIABIL Short Wire Biliary Endoprosthesis 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia and Rhode Island named
- Medical device recall GORE VIABIL Short Wire Biliary Endoprosthesis 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia and Rhode Island named
- Medical device recall Brand Name: Xhibit Product Name: Xhibit Central Station Due to off-the-shelf display port component that has audio/video failures Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Boston Scientific Enhance Transcarotid/Peripheral Access Kit Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436… Product may contain a perforation or tear in the sterile barrier packaging. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL… Product may contain a perforation or tear in the sterile barrier packaging. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 Product may contain a perforation or tear in the sterile barrier packaging. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 Product may contain a perforation or tear in the sterile barrier packaging. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Product may contain a perforation or tear in the sterile barrier packaging. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Micro-Kill Bleach Germicidal Bleach Wipes,7” x 8”, 150 count, 150 count, Product Number MSC351400AN Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6” x 5”, 150 count, Product Number MSC351410AN Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12” x 12”, 110 Count, Product Number MSC351450AN Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
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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