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 5, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Halyard IV START KIT NON-STERILE Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered… There is an error in the product description on the Unique Device Identification (UDI) label. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRO+ 36” MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of… There is an error in the product description on the Unique Device Identification (UDI) label. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRO+ 40” MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of… There is an error in the product description on the Unique Device Identification (UDI) label. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PEDS SINUS PACK The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) MAJOR PACK The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) MFC CRANIOTOMY PACK The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) MAJOR NEURO VCH The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ANTERIOR SPINE PACK The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Class IIFDA’s classSep 30, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Power-Trialysis Short-Term Straight Dialysis Catheter this is a downstream recall of class I recall RES 98777 FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report50 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereAlabama, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall DuoGlide Short-Term Straight Dialysis Catheter this is a downstream recall of class I recall RES 98777 FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report50 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereAlabama, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron… Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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 Halyard IV START KIT NON-STERILE Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide, and Nebraska named
- Medical device recall Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) OPEN HEART ADULT The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ACC010308A The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYKM1000B The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYNDH1193 The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYNDB3086D The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall StatStrip Glucose Hospital Meter System A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall StatStrip Glucose Hospital Meter System A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall StatStrip Glucose and B- Ketone meter A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall StatStrip Glucose and B- Ketone meter A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall StatStrip Glucose and B- Ketone meter A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Philips Patient Information Center iX Due to software malfunction, patient information system may freeze and become unresponsive. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 23, 2026ClassClass 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 Philips PIC iX Essentials Due to software malfunction, patient information system may freeze and become unresponsive. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 23, 2026ClassClass 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 Carescape Central Station CSCS V3 MAS800 Desktop Device may not resume patient monitoring for at least 3 minutes following system restart. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percutaneous Insertion Kit (PIK), Guidewire 100 cm The packaging may not consistently maintain sterile barrier integrity. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percutaneous Insertion Kit (PIK), Guidewire 150 cm The packaging may not consistently maintain sterile barrier integrity. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Percutaneous Insertion Kit (PIK), dilator set L The packaging may not consistently maintain sterile barrier integrity. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System Some devices may not have been properly sterilized due to a manufacturing sterilization issue. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Automated Impella Controller (AIC) with the below product descriptions and corresponding The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella Optical Controller with the below product descriptions and corresponding The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product… The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Haylard 18G SINGLE SHOT EPI TRAY Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereIllinois, North Carolina, Virginia and Wyoming
- Medical device recall Haylard CONTINUOUS NERVE BLOCK TRAY Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereIllinois, North Carolina, Virginia and Wyoming
- Medical device recall Haylard BASIC BIOPSY TRAY Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereIllinois, North Carolina, Virginia and Wyoming
- Medical device recall Haylard UNIV IMAGING BIOPSY TRUCUSTOM Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 23, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 23, 2026ClassClass IStatusOngoingWhereIllinois, North Carolina, Virginia and Wyoming
- Medical device recall Plum administration sets Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IV Non-Dedicated Gravity Administration Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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