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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32251–32275 of 40449

  • 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
  • ModerateFDA (Devices)·Z-2473-2015·2015-09-02

    Baxter MiniCap Extended Life PD Transfer Set Labeling Recall

    Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set. Product Code 5C4449. 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 performed at the transfer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2015·2015-09-02

    Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy

    Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.

    Product
    Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2015·2015-09-02

    Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues

    Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.

    Product
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2471-2015·2015-09-02

    Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates

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

    Product
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2476-2015·2015-09-02

    AMUSA Recalls 0.9% Sodium Chloride Injection Due to Process Control Issues

    MRP, LLC dba AMUSA is recalling 0.9% Sodium Chloride Injection because procedures for product acceptance and control were not adequately established.

    Product
    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-2367-2015·2015-08-26

    Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2372-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

    Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

    Product
    Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2329-2015·2015-08-26

    FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects

    The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.

    Product
    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2343-2015·2015-08-26

    Draeger Evita Infinity V500 Ventilator Battery Recall

    Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

    Product
    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2437-2015·2015-08-26

    Siemens Intevo Series Imaging Systems Recalled for Overheating Risk

    Siemens Medical Solutions USA is recalling 185 Intevo Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
    Category
    Medical Device
    Distribution
    51 states