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 MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A 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: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A 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) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C 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) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A 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 BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall… 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: DR FERNANDEZ, Medline kit number/SKU DYNJ68808 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: NURSING KIT, Medline Kit Number/SKU EDUC1044 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) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G 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) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B 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: PELVIC LAP PACK, Medline Kit Number/ 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 BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS… 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) D AND C PACK, Medline Kit Number/SKU DYNJ53973C 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 CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER… 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: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY… 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) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I 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) CRANI, Medline Kit Number/SKU DYNJ908097 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 Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR… Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Washington, Wisconsin and West Virginia named
- Medical device recall iLet Bionic Pancreas The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD Connecta” BD Luer-Lok” 360 Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening… Class IIFDA’s classJun 24, 2026in FDA’s Enforcement Report39 statesnamed in where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Brand Name: Inspire Medical Systems, Inc Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Inspire Medical Systems, Inc Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Splashwire Hydrophilic Guide Wire Due to unsealed portions of pouches. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Due to 11 volt Backup Battery failures. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate 3” System Controller Due to 11 volt Backup Battery failures. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Due to 11 volt Backup Battery failures. Class IIFDA’s classJun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedJun 24, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Fresh Roast Systems ColorTrack A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Plum Solo Precision IV Pump, 40001-0401 Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Plum Duo Infusion Pump, 40002-0401 Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Plum Duo Precision IV Pump, 40002-0403 Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Allia IGS 3 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allia IGS 7 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allia IGS Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mahurkar Elite PASS Trays The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts and South Carolina named
- Medical device recall Bicarby” Dialysate Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and New York, Tennessee and Texas named
- Medical device recall TDC VELOCE”, 23G Two Dimensional Cutter - 20k CPM An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TDC VELOCE”, 25G Two Dimensional Cutter - 20k CPM An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TDC VELOCE”, 27G Two Dimensional Cutter - 20k CPM An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CGuard Prime Carotid Stent System, 135cm, 9mx30mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING… Due to incorrect incubation process being performed on product. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING… Due to incorrect incubation process being performed on product. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin 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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