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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4501–4525 of 39824

  • HighFDA (Devices)·Z-1203-2025·2025-02-26

    Dexcom G6 glucose receiver may fail to deliver high or low alarms

    Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2025·2025-02-26

    RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency

    RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2025·2025-02-26

    RayStation radiation therapy software recall for density calculation inconsistency

    RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2025·2025-02-26

    Radiation Therapy Planning System Density Calculation Inconsistency in RayStation

    RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2025·2025-02-26

    Medline Respiratory Intubation Kits Recalled for Reduced Skin Barrier Wear

    Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.

    Product
    Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1204-2025·2025-02-26

    Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms

    The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2025·2025-02-26

    RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency

    RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2025·2025-02-19

    Sevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk

    A sevoflurane vaporizer component may degrade to hydrogen fluoride, causing respiratory damage and chemical burns to patients and workers. FDA classified this Class I recall affecting six units in Kentucky and Connecticut.

    Product
    Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1165-2025·2025-02-19

    Exactech AcuMatch XLE Hip Implant Liner Recall

    Exactech is recalling certain AcuMatch XLE hip implant liners due to a missing ethylene vinyl alcohol barrier layer. The missing barrier may affect the implant's performance.

    Product
    AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Devices)·Z-1116-2025·2025-02-19

    Wheelchair Speed Control Remote Recalled Due to Loss-of-Control Risk

    The Smart Drive MX2+ SpeedControl Dial remote is being recalled due to a faulty circuit board that could cause loss of control of the wheelchair power assist, potentially resulting in injury.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1117-2025·2025-02-19

    Wheelchair Power Assist Speed Control Dial Recalled for Loss of Control Risk

    Max Mobility Smart Drive MX2+ SpeedControl Dial wheelchairs are being recalled due to faulty circuit boards that may cause loss of device control, potentially resulting in injury to users.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1071-2025·2025-02-19

    Olympus Guide Sheath Kits recalled for potential radiopaque tip detachment

    Olympus Single Use Guide Sheath Kits (models K-201 through K-204) are recalled because the radiopaque tip of the guide sheath may detach and fall into the patient during respiratory procedures.

    Product
    Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2025·2025-02-19

    MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect

    Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.

    Product
    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling certain Presource ACDF Kits due to potential endotoxin contamination in non-sterile surgical strips and patties used in spinal fusion procedures.

    Product
    Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1140-2025·2025-02-19

    Cardiac Diagnostic Implant Recalled for Premature Device Failure

    Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.

    Product
    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2025·2025-02-19

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2025·2025-02-19

    Stryker Precision Thin surgical blade attachments recalled for specification defect

    Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1166-2025·2025-02-19

    Novation XLE hip implant components recalled for missing barrier layer

    Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.

    Product
    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1131-2025·2025-02-19

    Cardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.

    Product
    Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2025·2025-02-19

    Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination

    Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.

    Product
    Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2025·2025-02-19

    Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities

    CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.

    Product
    (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
    Category
    Medical Device
    Distribution
    Distributed nationwide