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 Pi-Cardia Inc Transfemoral catheter, positing arm may detached due to weld issue. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Delaware, Kansas, Massachusetts, New Hampshire, New York, Pennsylvania and Utah named
- Medical device recall Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack,… Capsule may fail to attach to the esophagus or detach from the delivery device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 16, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Kit: Epidural/Pain TQC 20/Cs Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2026in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 16, 2026ClassClass IStatusOngoingWhereFlorida, Iowa, Kansas, Missouri, Ohio and Virginia
- Medical device recall Kit: Single Shot Epidural 20/Cs Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 16, 2026in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 16, 2026ClassClass IStatusOngoingWhereFlorida, Iowa, Kansas, Missouri, Ohio and Virginia
- 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 lacks sterility assurance due to to wrinkles in the paper lidding… Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Nebraska named
- Medical device recall Product Name: DermaV Laser System Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in… Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Products that contain the Pericare Wipes: *Bardex¿ I.C Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Products that contain the Pericare Wipes: SureStep” Foley Tray System Add-A-Foley Catheter Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Products that contain the Pericare Wipes: (Canada Only) SureStep” Foley Tray System Bardex¿ IC Complete Care¿ Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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, Washington, Wisconsin and Wyoming named
- Medical device recall HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US… Due to a damaged (over stretched) membrane tail that causes an intermittent fault. Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MedicaLyte Liquid Bicarbonate Concentrate Hemodialysis concentrates contain high endotoxin levels Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio and Pennsylvania named
- Medical device recall MedicaLyte Bicarbonate Powder Hemodialysis concentrates contain high endotoxin levels Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio and Pennsylvania named
- Medical device recall Citric Complete Dry Citric Acid Concentrate Hemodialysis concentrates contain high endotoxin levels Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio and Pennsylvania named
- Medical device recall Citric Complete Liquid Citric Acid Concentrate Hemodialysis concentrates contain high endotoxin levels Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio and Pennsylvania named
- Medical device recall AMS Convenience Kit: DSAEK Pack - RX The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that… Class IIFDA’s classSep 16, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 16, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Georgia and Washington named
- Medical device recall Philips Brilliance Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips IQon Spectral CT Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Ingenuity CT Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Brilliance CT 64: Brilliance CT 64 Channel Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Halyard medical convenience kits labeled as: 1) ENT The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wyoming named
- Medical device recall 1) NEURO, (kit) ACNE73-01 The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wyoming named
- Medical device recall Halyard medical convenience kits labeled as: 1) A-P PACK - 205936 The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, Ohio, Pennsylvania, South Dakota, Texas, Utah, Washington and Wyoming named
- Medical device recall STA Staclot Protein S A positive drift in QC values within the reagent’s stated 4-hour onboard stability period was identified Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Virginia named
- Medical device recall Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) CDS840396X The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYKM1414 The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) COLORECTAL ME The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ULTRASOUND BREAST PACK The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) IV START KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PRE-OP KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) LABOR CDS The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) C-SECTION PREP The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) EYE KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ORTHO ASPIRATION KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BLOOD DRAW KIT The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HEALON EndoCoat PRO Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Baxter Novum IQ Syringe Pump A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Baxter Novum IQ Syringe Pump, Loaner A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia 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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