Medical devices
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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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Philips Ingenia Elition X with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips MR 7700 with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Upgrade to MR 7700 with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dimension Creatinine Flex reagent cartridge Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD GasPak EZ CO2 Pouch System BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD GasPak EZ Campy Pouch System BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Immy, Myco DDR Trident, Bulk Neutralization Buffer B Neutralization Buffer may contain contaminants Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Indiana, Michigan, Missouri, Mississippi, North Carolina, South Carolina, Texas and Washington named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota, North Carolina and Texas named
- Medical device recall Straumann n!ce PMMA Full-arch Restoration Includes an incorrect screw seat interface. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio and Virginia
- Medical device recall Straumann n!ce Zr, HT, Full-arch Restoration Includes an incorrect screw seat interface. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, Florida, Hawaii, Louisiana, Maryland, Ohio and Virginia
- Medical device recall iLet Bionic Pancreas insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, Georgia, Michigan, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Heraeus, PALAMIX uno Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its… Class IIIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Heraeus, PALAMIX duo Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its… Class IIIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall i-STAT EG7+ cartridge Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall i-STAT EG6+ cartridge Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall i-STAT G3+ cartridge Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Bridge Prep Kit catheter may experience resistance when being advanced over the guidewire Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall Philips Bridge Prep Kit catheter may experience resistance when being advanced over the guidewire Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall Philips Bridge Prep Kit catheter may experience resistance when being advanced over the guidewire Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado named
- Medical device recall epoc BGEM BUN Test Card Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial,… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Leksell Vantage Arc System Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement Report32 statesnamed in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Medline Neuro Sponges, various dimensions, labeled as: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK,… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY,… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline and Centurion medical procedure kits, containing Medline Neuro Sponges During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state 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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