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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3826–3850 of 13543

  • 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-1175-2025·2025-02-26

    3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.

    Product
    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2025·2025-02-26

    Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly

    Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
    0 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-1133-2025·2025-02-19

    Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
    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-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2025·2025-02-19

    Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings

    Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.

    Product
    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.

    Product
    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.

    Product
    Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2025·2025-02-19

    Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk

    Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.

    Product
    Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2025·2025-02-19

    BD Pyxis MedStation ES Medication Cabinet Drawer and Door Failures Recalled

    The FDA is recalling BD Pyxis MedStation ES medication cabinets due to potential drawer and door failures that could delay medication access. Affected healthcare facilities should check their devices and contact the manufacturer if malfunctions occur.

    Product
    BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
    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-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-1134-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2025·2025-02-19

    Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer

    Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.

    Product
    Alteon 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-1138-2025·2025-02-19

    Stryker Precision Thin Blade Attachments Recalled for Measurement Failure

    Stryker Corporation is recalling 622 units of Precision Thin blade attachments that may be out of measurement specifications, preventing them from fitting securely into compatible handpieces.

    Product
    stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource ACDF Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource ACDF surgical kits for potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses or injuries have been reported.

    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-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-1164-2025·2025-02-19

    Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures

    Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.

    Product
    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.

    Product
    Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR
    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