Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Design Options, Pain Management Tray Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Design Options, PERIFIX FX Epidural Anesthesia Tray Potential for the lid of the catheter connector to be in the incorrect position. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55 The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusCompletedWhereMassachusetts and Rhode Island
- Medical device recall NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90 The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusCompletedWhereMassachusetts and Rhode Island
- Medical device recall NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55 The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusCompletedWhereMassachusetts and Rhode Island
- Medical device recall NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90 The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 15, 2025ClassClass IIStatusCompletedWhereMassachusetts and Rhode Island
- Medical device recall Allura Xper FD10C The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10/10 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD10 OR Table The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 Biplane OR Table The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20 OR Table The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/10 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 OR Table The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 OR Table The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper CV20 The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardio Vascular-Allura Centron The BIOS battery may deplete faster than initially anticipated during the design phase. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Getinge 88-Series Washer- Disinfector Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Massachusetts, New Hampshire and New Mexico named
- Medical device recall IMPLANT EPIKUT PLUS MT16 3,5X10,0MM Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Kansas, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall AESCULAP ELAN 4 FIXED DURAGUARD STANDARD Mislabeling. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 8, 2025ClassClass IIStatusOngoingWhereMissouri
- Medical device recall AESCULAP ELAN 4 FIXED DURAGUARD LONG Mislabeling. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 8, 2025ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Change Healthcare Radiology Solutions software version 14.2.2 Due to software issue, radiology reports may not be fully displayed when viewing. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Florida, Indiana, Louisiana, Massachusetts, New Jersey, Washington and Wisconsin named
- Medical device recall DxC 500 AU Module w/ISE, DxC 500i, With ISE On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic, Simplera Sensor The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Artegraft Collagen Vascular Grafts The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Mississippi, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall GORE ACUSEAL Vascular Graft Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement Report51 statesnamed in where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereAlaska, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Sterile Medline Convenience Kits: 1) MAJOR PACK L-F Convenience kits labeled as sterile have not gone through the sterilization process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereFlorida, Maryland, New Jersey and Tennessee
- Medical device recall Sterile Medline Convenience Kits: 1) EXTREMITY PACK Convenience kits labeled as sterile have not gone through the sterilization process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereFlorida, Maryland, New Jersey and Tennessee
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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