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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9701–9725 of 27470

  • HighFDA (Devices)·Z-1410-2022·2022-07-27

    Modulift VBR Surgical Screwdriver Fails Due to Tip Deformation

    Aesculap is recalling the Modulift VBR 4MM set screwdriver due to tip deformation during surgical engagement with implants. The device is distributed in CA, FL, GA, IL, OH, and MI.

    Product
    MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1431-2022·2022-07-27

    BD Connecta Infusion Stopcock Recall Due to Potential Housing Leakage

    BD Connecta Stopcock infusion devices may leak at the housing component, potentially delaying or interrupting treatment and exposing patients to biohazardous material. The recall affects 485,000 units distributed worldwide.

    Product
    BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2022·2022-07-27

    Sensis diagnostic tool software may fail to display vital signs

    Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

    Product
    Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2022·2022-07-27

    BD Connecta Plus3 infusion connector recalled for potential stopcock leakage

    Becton Dickinson is recalling BD Connecta Plus3 White Blend infusion connectors (Lot 1127328) due to potential stopcock leakage. The defect may interrupt treatment, expose patients to biohazardous material, or cause under-infusion.

    Product
    BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2022·2022-07-27

    BD Connecta Stopcock Recalled for Potential Housing Leakage

    Becton Dickinson is recalling its BD Connecta Stopcock due to potential leakage at the housing component, which may interrupt treatment and cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2022·2022-07-27

    Surgical Coronal Bender May Deform Spinal Implants During Surgery

    Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.

    Product
    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1419-2022·2022-07-27

    Orthopedic Surgical Guide with Defective Spring Subject to Corrosion

    DePuy Orthopaedics is recalling 872 units of the ATTUNE Measured Sizing and Rotation Guide due to a manufacturing defect. A galvanized steel spring was used instead of stainless steel, which may cause corrosion and surgical complications.

    Product
    ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2022·2022-07-27

    Surgical knee implant instrument key may become nonfunctional during assembly

    Aesculap is recalling the ENDURO SPECIAL KEY TIB.LOCK.RING (product code NP462R) used in knee replacement surgery because the key pins may be damaged during assembly, causing the instrument to become nonfunctional.

    Product
    ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2022·2022-07-27

    SIGNA Premier MRI scanner recalled for elevated acoustic noise hazard

    GE Healthcare's SIGNA Premier MRI scanner is being recalled because under rare conditions, the gradient coils can produce elevated acoustic noise that could potentially cause hearing loss with prolonged exposure.

    Product
    SIGNA Premier magnetic resonance scanner, model 5748519.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2022·2022-07-27

    SurgiCount+ System software error bypasses sponge tracking alerts

    A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.

    Product
    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1440-2022·2022-07-27

    Nexiva Infusion Device Stopcock May Leak During Treatment

    Becton Dickinson is recalling Nexiva infusion devices with pink stopcock components due to potential leakage at the housing that could interrupt treatment or expose patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1349-2022·2022-07-20

    CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports

    Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.

    Product
    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1372-2022·2022-07-20

    Blood gas test device recalled for inaccurate oxygen measurements

    Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.

    Product
    epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1347-2022·2022-07-20

    CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia

    Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.

    Product
    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1346-2022·2022-07-20

    CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints

    Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.

    Product
    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1373-2022·2022-07-20

    Alcon Custom Pak Surgical Procedure Packs recalled for incorrect latex gloves

    Alcon has recalled 320 kits of Custom Pak Surgical Procedure Packs distributed across Arizona, California, Missouri, and New York because they contain latex gloves instead of the specified non-latex gloves, creating an allergen hazard for sensitive patients.

    Product
    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1377-2022·2022-07-20

    Modular Orthopedic Implant Screws May Not Loosen During Surgery

    FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.

    Product
    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1371-2022·2022-07-20

    Hemodialysis Dialysate Recalled for Unqualified Bottle Caps

    Fresenius Medical Care is recalling NATURALYTE Liquid Acid dialysate because bottle caps are not qualified for use. The recall affects 163 cases of lot 22CTAC102 distributed nationwide.

    Product
    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1374-2022·2022-07-20

    Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk

    Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.

    Product
    Ventana HE 600 System, automated slide preparer, for use in laboratories.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1355-2022·2022-07-20

    MiniMed 670G Insulin Pump Battery Cap Defect Causing Power Loss

    MiniMed 670G Insulin Pump may lose power due to battery cap deterioration, affecting approximately 279,251 units distributed in the U.S. and overseas.

    Product
    MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1362-2022·2022-07-20

    Pressure Monitoring Sets with Excess Coating Pose Embolism Risk

    Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.

    Product
    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2022·2022-07-20

    Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect

    Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.

    Product
    Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
    Category
    Medical Device
    Distribution
    15 states