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 Micro-Kill Bleach Germicidal Bleach Wipes, 12” x 12”, 110 Count Bag, Product Number MSC351450BG4 Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901 Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD Firmware issue potentially leading to loss of geometry movements. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GM Helix Implant, Endosseous Dental Implant Article No. 109.984 There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion Rystem Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Azurion Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportIndianathe one state its words name PublishedAug 19, 2026ClassClass IIStatusOngoingWhereIndiana
- Medical device recall Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314) Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BIOFIRE Respiratory Panel 2.1 (RP2.1) Due to increase in false negative results Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas and Wisconsin named
- Medical device recall ProNephro AKI (NGAL) Reagent Kit The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ERBECRYO 2 Cryosurgical Unit A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in… Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 19, 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 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and… Products may not have received adequate sterilization processing. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement Report26 statesnamed in where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) NEWNAN SMR PACK Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) ENT TRAY Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) SEPTO RHINO PACK Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health Presource Kits: 1) BASIC PACK Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IStatusOngoingWhereNationwide, and North Carolina and Texas named
- Medical device recall Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IStatusOngoingWhereNationwide, and North Carolina and Texas named
- Medical device recall Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IStatusOngoingWhereNationwide, and North Carolina and Texas named
- Medical device recall REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data… Due to software issues where does not handle combo assay results. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereFlorida, Georgia, Illinois, Michigan and Pennsylvania
- Medical device recall Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation… Charging cradle for the device may overheat while charging the device’s removable battery pack, presenting risk of thermal event (fire). Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12) Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Kingfisher Compact Individual First Aid Kit Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1 Potential for breach in sterile barrier of device packaging. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1 Potential for breach in sterile barrier of device packaging. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5 Potential for breach in sterile barrier of device packaging. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Quantum Outback If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: R-TRAK If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Q6 Edge HD If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Quantum 1450 If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Q6 Edge 3 If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Q6 Edge 4 If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: 4Front If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: Quantum Rehab Product Name: Quantum Rival If the “Remind Me Later” option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, West Virginia and Wyoming named
- Medical device recall Brand Name: WASPLab Product Name: WASPLab Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona named
- Medical device recall Nerivio Infinity Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses… A software issue may cause the wheelchair’s driving mechanism to fall out of calibration. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, North Carolina, Texas, Utah and Washington 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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