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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes XXX Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OER-ELITE Endoscope Reprocessor Connecting Tubes Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow Echogenic Introducer Needle Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall ARROW RADIAL ARTERY CATHETERIZATION KIT Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall MAC” Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall Arrowg+ard Blue¿ MAC” Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia named
- Medical device recall Rover Mobile X-ray System X-Ray generator may malfunction resulting in the X-Ray being inoperable. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey, Puerto Rico and Washington named
- Medical device recall Custom Convenience Kits Pre Op Kit - NS The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia, Oregon, Tennessee and Washington named
- Medical device recall Custom Convenience Kits Pre Op Kit - NS The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia, Oregon, Tennessee and Washington named
- Medical device recall Custom Convenience Kits Pre Op Kit - NS The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia, Oregon, Tennessee and Washington named
- Medical device recall Access Total T4 Calibrator Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Ohio, South Dakota, Texas and Washington named
- Medical device recall Flamingo Funnel Small Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas and Utah named
- Medical device recall Flamingo Funnel Medium Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas and Utah named
- Medical device recall Flamingo Funnel Large Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas and Utah named
- Medical device recall Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts and North Carolina named
- Medical device recall LSL Healthcare, Central Line Dressing Kit Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall LSL Healthcare, Standard Central Line Dressing Change Kit Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall LSL Healthcare, Foley Urine Collection Kit Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall LSL Healthcare, Infant Central Line Dressing Change Kit Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall LSL Healthcare, IV Start Kit Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall LSL Healthcare Wound Closure Tray Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland and Minnesota named
- Medical device recall Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx… Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereMassachusetts and North Carolina
- Medical device recall Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Virginia
- Medical device recall Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Virginia
- Medical device recall Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Virginia
- Medical device recall Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Virginia
- Medical device recall Omnipod 5 Pods Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips AneurysmFlow Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Yeastone Broth, 11ML, 10/BOX YY3462 Products may report incorrect AST results during quality control. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide
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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