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 Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Due to a defective circuit board that overheats Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Indiana, South Carolina, Texas and Virginia named
- Medical device recall Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Texas named
- Medical device recall Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i… Events observed where anesthetic agent was not delivered when the vaporizer was activated. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named
- Medical device recall Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall STRYKER AHTO TUBE SET PACKAGING There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRYKER AHTO TUBE SET WITH TIP PACKAGING There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRYKER PKG., SINGLE SPIKE TUBE SET There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intramedullary Bone Saw Blade Assembly Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier… 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 Intramedullary Bone Saw Blade Assembly Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier… 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 Intramedullary Bone Saw Blade Assembly Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier… 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 Intramedullary Bone Saw Blade Assembly Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier… 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 Intramedullary Bone Saw Blade Assembly Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier… 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 Merge PACS, medical imaging diagnostic workstation Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Merge OrthoPACS, medical imaging diagnostic workstation Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare MAC VU360, REF# Software issue issue with the MAC VU360 v3.0 system. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FilmArray NGDS Warrior Panel Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Hawaii, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, Nevada, New York, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall GE Healthcare Portrait Core Services SW V 1.2.0 A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan named
- Medical device recall INFINION CX LEAD KIT, 50CM Spinal cord stimulation system lead body may be exposed to stress at the anchor site. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 12, 2026ClassClass IStatusOngoingWhereNew York
- Medical device recall Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. Class IIIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIIStatusOngoingWhereNationwide, and California and Virginia named
- Medical device recall Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. Class IIIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 12, 2026ClassClass IIIStatusOngoingWhereNationwide, and California, Idaho, Illinois, Indiana, Massachusetts, Northern Mariana Islands, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania and Washington named
- Medical device recall Happiest Baby, Inc Pre-loved SNOO Smart Sleeper This recall is retroactively being reported. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey, Pennsylvania and Washington named
- Medical device recall Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral… Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall HardyDisk AST Cefiderocol 30¿g (FDC30) Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Idaho, Indiana, Massachusetts, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania and Tennessee named
- Medical device recall REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments:… Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.” Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280… Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.” Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall Atellica CH Urine Albumin Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Philips Allura under the following System Descriptions and corresponding Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion under the following System Descriptions and corresponding Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura, Cardio Vascular-Allura Centron Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 5-PLASMA Bivalirudin AMR Verification Kit Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, North Carolina and Tennessee named
- Medical device recall 5-PLASMA Bivalirudin Calibrator Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, North Carolina and Tennessee named
- Medical device recall 5-PLASMA Bivalirudin Control Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, North Carolina and Tennessee named
- Medical device recall Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and Texas named
- Medical device recall GEM Premier 7000 with iQM3 The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Virginia, Wisconsin and West Virginia named
- Medical device recall GEM Premier 5000 PAK The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Virginia, Wisconsin and West Virginia named
- Medical device recall Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania 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.”
Your shortlist0 of 4
Add one more to compare.