Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Covidien Signia” Small Diameter Curved Tip Intelligent Reload Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blood Pressure Unit The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trumpet, Needle Guide The Ring on the Trump Needle Guide can detach when excessive pressure is applied. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count Product was mislabeled as a Surgical Cap at its dispenser level. Class IIIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 10, 2024ClassClass IIIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Minnesota, Missouri, Montana, South Dakota, Tennessee, Texas and Washington named
- Medical device recall Agfa DX-D 100 system-Digital Radiography mobile X-ray System Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ureteral dilator A possible sterility issue (e.g. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereArizona, Georgia, Kansas, Louisiana, Maryland, Minnesota, Mississippi, Tennessee and Washington
- Medical device recall Covidien Auto Suture” Structural Balloon Trocar, Product Number OMS-T10SB The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T10BTNL The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T10BTSNL The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T12BT The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T10BTS The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T10BT The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Auto Suture” Blunt Tip Trocar, Product Number OMS-T12BTNL The potential for trocar seal disengagement when using mesh products incorrectly with the device. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Karl Storz SE & CO Inadequate reprocessing validation evidence Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Karl Storz SE & CO Inadequate reprocessing validation evidence Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall Karl Storz SE & CO Inadequate reprocessing validation evidence Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall stryker Infinity Resection Adjustment Block Stryker has identified an issue that impacts specific lots of Infinity” Resection Guide Adjustment Blocks. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNebraska and Texas
- Medical device recall NaviNetics Skull Anchor Key and Drill Kit Defective Skull Anchor Key. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida and Minnesota named
- Medical device recall ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Customer complaints were received regarding falsely elevated results for some patient samples. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity i Anti-HCV Reagent Kit, List Number 08P0521 Customer complaints were received regarding falsely elevated results for some patient samples. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nimbus Administration Set InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Nimbus II Infusion System InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Boston Scientific POLARSHEATH Steerable Sheath 12F Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall stay-safe /Safe Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall stay-safe /Luer Lock Adapter 4 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall stay-safe /Luer Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall stay-safe /Luer Lock Catheter Ext. 18 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall stay-safe /Luer Catheter Ext. 6 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Minnesota, Pennsylvania, South Dakota and Texas named
- Medical device recall Thermalon Eye Compress Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Sinus Compress (French) Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Sinus Compress Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Back Wrap Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Neck Wrap Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Heating Pad Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thermalon Stye Compress Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MediBeads Neck Wrap Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MediBeads King Pad Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus… Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on… Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California and Indiana named
- Medical device recall SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070 Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Ohio and West Virginia named
- Medical device recall Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification… Use of assay along with plasma specimen may result in error code which would invalidate sample. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Idaho, Illinois, Maryland, Michigan, Missouri, Tennessee, Texas and Wisconsin named
- Medical device recall VITROS Performance Verifier I The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Performance Verifier II The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Insufflation unit, UHI-4. Olympus has become aware of an increased trend of both repairs and customer complaints reporting “UHI-4 stopping air supply due to the front panel LED turning… Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.