Medical devices
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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 Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007… Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: PORT A CATH DYNJ906818A Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B… Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291 Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION… Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lighting system’s light heads. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic O-arm O2 Imaging System Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Impella CP Set with SmartAssist Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 24, 2026ClassClass IStatusOngoingWhereGeorgia, Iowa, Nebraska, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereCalifornia, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas and Virginia
- Medical device recall Ritmed Neurological Sponges, 0.75x0.75in, Sterile Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereCalifornia, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas and Virginia
- Medical device recall directCHECK ACT-LR whole blood quality control, level 2 Assayed Whole blood control contains labeling with incorrect performance range. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall TRI TS BASEPLATE SIZE 3 Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Michigan, North Carolina, New Jersey, New York and West Virginia named
- Medical device recall TRI TS BASEPLATE SIZE 4 Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Michigan, North Carolina, New Jersey, New York and West Virginia named
- Medical device recall ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length Potential for overpressure alerts. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an… GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Giraffe OmniBed Field Replaceable Unit (FRU) GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mito Red Light, Super Mobile The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1 During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1 During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF)… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271 During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR… During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5’S PK, Medline Kit Number/SKU DYNJ0040839 During an internal review, Medline identified representative samples did not meet applicable performance specifications. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 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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