The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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6476–6500 of 27364

  • HighFDA (Devices)·Z-0639-2024·2024-01-10

    Spinal fixation screws recalled due to incorrect size laser marking

    Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.

    Product
    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2024·2024-01-10

    Philips Trilogy Evo respiratory devices recalled for missing contraindication statement

    Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.

    Product
    Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2024·2024-01-10

    Surgical Knife Crescent Recall Due to Incorrect Blade Angle

    Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.

    Product
    Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0623-2024·2024-01-10

    Medtronic Protege GPS Stent System Recalled for Packaging Seal Defects

    Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.

    Product
    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2024·2024-01-10

    Merit Maestro Microcatheter Sterility Recall, 717 Units Distributed Worldwide

    Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.

    Product
    Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2024·2024-01-10

    EDS 3 CSF External Drainage System recalled for incomplete sterility testing

    Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.

    Product
    EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2024·2024-01-10

    Covidien Valleylab FT10 Energy Platform software issue causes inoperability

    Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.

    Product
    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2024·2024-01-10

    FDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns

    Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.

    Product
    Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0599-2024·2024-01-03

    Megadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries

    Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.

    Product
    Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0600-2024·2024-01-03

    Megadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports

    Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.

    Product
    Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0597-2024·2024-01-03

    MEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries

    Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.

    Product
    Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2024·2024-01-03

    Megadyne Patient Return Electrodes Recalled Due to Serious Burn Risk

    Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.

    Product
    Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0563-2024·2024-01-03

    Medline Nurse Training Kits Recalled for Sharp Tracheostomy Brush

    Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.

    Product
    (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0562-2024·2024-01-03

    Medline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect

    Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.

    Product
    (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0561-2024·2024-01-03

    Medline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment

    Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.

    Product
    Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2024·2024-01-03

    Medtronic SynchroMed II Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.

    Product
    Medtronic SynchroMed II, Model 8637-20, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0611-2024·2024-01-03

    Arjo Medical Beds Recalled Due to Unintended Wheel Movement

    Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0613-2024·2024-01-03

    Alinity ci-series System Control Module Software Performance Issues Recalled

    Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.

    Product
    Alinity ci-series System Control Module, REF: 03R70-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0615-2024·2024-01-03

    Medtronic SynchroMed II Programmable Pump May Fail to Resume Drug Delivery After MRI

    The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.

    Product
    Medtronic SynchroMed II, Model 8637-40, Programmable pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2024·2024-01-03

    Arjo medical beds with unintended wheel movement recalled

    Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0616-2024·2024-01-03

    Landauer microSTARii reader recalled for measurement inaccuracy

    Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.

    Product
    Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0621-2024·2024-01-03

    Atrium Oasis surgical drain recalled for premature sterilization expiration

    Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.

    Product
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2024·2024-01-03

    DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers

    DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.

    Product
    DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0513-2024·2023-12-27

    FDA Recalls Sterile Water and Saline Bottles for Sterility Assurance Issues

    Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.

    Product
    Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT001
    Category
    Medical Device
    Distribution
    Distributed nationwide