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 the agency’s own highest classification or reported deaths or serious injuries, 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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20126–20150 of 40124

  • HighFDA (Devices)·Z-1981-2019·2019-07-24

    DeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect

    DeRoyal is recalling 108 custom surgical packs in Oklahoma because they contain defective Cardinal Health Blunt Cannulas that could compromise sterility.

    Product
    DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1951-2019·2019-07-24

    GE Healthcare Recalls Revolution CT Scanners Due to Radiation Exposure

    GE Healthcare is recalling Revolution CT scanners because they may expose patients to additional low-dose radiation.

    Product
    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2019·2019-07-24

    DJO Aircast Sterile Cuff Recall Due to Sterility Concerns

    DJO, LLC is recalling 9 units of Aircast REF 3011 sterile cuffs because they may not meet sterility requirements.

    Product
    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1967-2019·2019-07-24

    BD Microtainer Tubes Recalled Due to Reduced Anticoagulant Additive

    Becton Dickinson is recalling specific Microtainer tubes because they may contain reduced or no additive, causing blood samples to clot and delaying test results.

    Product
    BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1960-2019·2019-07-24

    Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation

    Zimmer Biomet is recalling 92 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.

    Product
    Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2019·2019-07-24

    Zimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation

    Zimmer Biomet is recalling 1,257 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.

    Product
    Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2019·2019-07-24

    Clariance Erisma-LP Posterior Fixation System Recalled for Screw Disassembly Risk

    Clariance Inc is recalling Erisma-LP posterior fixation system components due to a potential for polyaxial screws to disassemble during implantation.

    Product
    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2019·2019-07-24

    Electrode Conductivity Spray Solution Recalled for Antimicrobial Testing Failures

    Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failures in stability antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2019·2019-07-24

    Pharmaceutical Innovations Recalls Alpha Conducting Solution Due to Stability Testing Concerns

    Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution due to potential failures in stability antimicrobial effectiveness testing. The product was distributed in the US and internationally.

    Product
    Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2019·2019-07-24

    GE Healthcare Recalls Two Ultrasound Systems Due to Transducer Misalignment

    GE Healthcare is recalling two ultrasound systems because transvaginal probes may be misaligned. The devices were distributed in the US and internationally.

    Product
    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1973-2019·2019-07-24

    SpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk

    SpineFrontier, Inc. is recalling six A-CIFT SoloFuse Fixed Angle Drivers because they may bind when advancing fixation screws.

    Product
    A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1966-2019·2019-07-24

    Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

    Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

    Product
    Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1982-2019·2019-07-24

    Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues

    Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.

    Product
    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1979-2019·2019-07-24

    Roche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination

    Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.

    Product
    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1962-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Hose/Drape Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Hose/Drape Assemblies because there is insufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1963-2019·2019-07-24

    Zimmer Biomet Recalls Ultra-Drive Irrigation Tubing Assembly Due to Shelf Life Data

    Zimmer Biomet is recalling 8,478 Ultra-Drive Irrigation Tubing Assemblies because the company lacks sufficient data to support the labeled 10-year shelf life.

    Product
    Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist Electrode Conductivity Spray Solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2019·2019-07-24

    Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation

    Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.

    Product
    Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1969-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Electrode Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1974-2019·2019-07-24

    Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.

    Product
    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1975-2019·2019-07-24

    Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.

    Product
    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide