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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32151–32175 of 40325

  • HighFDA (Devices)·Z-2443-2015·2015-09-02

    Recall of Infant Heel Warmers Due to Potential Breakage and Spillage

    The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.

    Product
    Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2015·2015-09-02

    FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

    The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

    Product
    Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2015·2015-09-02

    Sunrise Medical Recalls Quickie IRIS Wheelchairs with Dynamic Backrest

    Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.

    Product
    Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2015·2015-09-02

    RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error

    RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.

    Product
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2466-2015·2015-09-02

    Sunrise Medical Recalls Quickie and Zippie IRIS Wheelchairs with MONO Backrest

    Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.

    Product
    Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2015·2015-09-02

    PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure

    PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.

    Product
    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2461-2015·2015-09-02

    Ferno iNX Wheeled Stretcher Wheel Caster Set Screw Recall

    Ferno-Washington Inc is recalling 26 Ferno iNX Wheeled Stretchers due to improperly installed wheel caster set screws that may allow bearing cups to back out.

    Product
    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2015·2015-09-02

    Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

    Product
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2015·2015-09-02

    Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal

    Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.

    Product
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2015·2015-09-02

    BD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns

    Becton, Dickinson and Company is recalling three lots of CD56 PE Cy 7 reagent because they contain a low amount of HLA-DR PE antibody, which could result in an unexpected staining pattern.

    Product
    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2472-2015·2015-09-02

    Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2015·2015-09-02

    Medtronic Guardian Real-Time Monitor Recalled for Finnish Translation Error

    Medtronic MiniMed is recalling 254 Guardian Real-Time Monitors distributed in Finland due to a language translation error that reverses the on-screen labels for LOW and HIGH glucose alerts.

    Product
    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2015·2015-09-02

    Iris Diagnostics Recalls iChemVELOCITY Urine Chemistry Systems for Labeling Error

    Iris Diagnostics is recalling iChemVELOCITY Automated Urine Chemistry systems because they do not maintain the claimed 5-day strip stability under specified conditions.

    Product
    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2463-2015·2015-09-02

    Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates

    Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.

    Product
    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2460-2015·2015-09-02

    ASO Recalls Carepak Bandages Due to Unlabeled Benzalkonium Chloride

    ASO, LLC is recalling Carepak Sheer Adhesive Bandages because 5/8 bandages contain 0.1% Benzalkonium Chloride, which is not listed on the label.

    Product
    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2475-2015·2015-09-02

    Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap

    Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.

    Product
    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2469-2015·2015-09-02

    GE Healthcare Recalls Centricity PACS-IW Systems Due to Missing Images

    GE Healthcare is recalling 82 Centricity PACS-IW systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2015·2015-09-02

    Advanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution

    Advanced Sterilization Products is recalling CIDEX Activated Dialdehyde Solution because it may lack adequate data to support its 24-month shelf life.

    Product
    CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2015·2015-09-02

    Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions

    Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2015·2015-09-02

    Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect

    Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.

    Product
    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2015·2015-09-02

    Trilliant Surgical Recalls Tiger Cannulated Screw System Tray Lids

    Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids because they are occasionally difficult to remove from sterilization trays.

    Product
    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2015·2015-09-02

    Trilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue

    Trilliant Surgical Ltd. is recalling 121 units of 3.0/4.0 Cannulated Drill Bits because the inner diameter is too small for the guide wire to pass through.

    Product
    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2015·2015-09-02

    Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect

    Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.

    Product
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    5 states