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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26626–26650 of 40233

  • ModerateFDA (Devices)·Z-2173-2017·2017-06-07

    Roche Recalls PreciControl Varia 3 Due to Typographical Error

    Roche Diagnostics is recalling 1,603 units of Elecsys PreciControl Varia 3 because the e-barcode and value sheet contain a typographical error for PTH target values.

    Product
    Elecsys PreciControl Varia 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2017·2017-06-07

    AbbVie Recalls PEG Kits Due to Missing or Duplicate Components

    AbbVie is recalling specific lots of PEG Kits due to potential defects including missing components, duplicate parts, or missing labels and instructions.

    Product
    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2017·2017-06-07

    Toshiba Angio WorkStation Recalled for Dose Tracking Display Error

    Toshiba is recalling 70 Angio WorkStation units because the Peak Skin Dose value may display incorrectly if the workstation is powered on after the Infinix system.

    Product
    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2166-2017·2017-06-07

    Siemens SHBG Immulite 2000 Reagent Recall Due to Stability Issues

    Siemens is recalling certain lots of SHBG Immulite 2000 reagents because they may not meet stability claims, potentially causing test bias.

    Product
    SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2165-2017·2017-06-07

    Pointe Scientific Lactate Dehydrogenase Reagent Set Recalled for Stability Issues

    Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase Reagent Sets because the product's stability claim is not being met.

    Product
    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2017·2017-06-07

    Cell Marque Recalls CD117 Reagents Due to Missing Export Labeling

    Cell Marque is recalling CD117, c-kit reagents because they were not labeled 'For Export Only' as required by the FD&C Act.

    Product
    CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2017·2017-06-07

    Acumed Recalls Slide-Loc Anatomic Radial Head System Due to Performance Issues

    Acumed LLC is voluntarily removing the Slide-Loc Anatomic Radial Head System from the market due to complaints about instrumentation performance, trial design, and implant dissociations.

    Product
    The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2216-2017·2017-06-07

    Zimmer Biomet Recalls Modular Hybrid Glenoid Base for Quality Issues

    Zimmer Biomet is voluntarily recalling 16 units of the Modular Hybrid Glenoid Base Large after two pieces with quality defects were shipped.

    Product
    Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2178-2017·2017-06-07

    AbbVie Recalls PEG Kits Due to Missing or Duplicate Components

    AbbVie is recalling 3,331 PEG kits distributed in the US and 31 other countries because they may have missing components, duplicate parts, or missing labels.

    Product
    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2017·2017-06-07

    Invacare Assist Bed Rail 6632 Recalled for Manual Typo

    Invacare is recalling 5,020 Assist Bed Rail 6632 units because a typo in the user manual could lead to incorrect installation.

    Product
    Assist Bed Rail - 6632
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2170-2017·2017-06-07

    Arrow VPS Access Kit Recalled for Missing Dressing Information

    Arrow International is recalling VPS Access Kits because they lack required information regarding the included 3M Tegaderm CHG dressing.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2210-2017·2017-06-07

    Cell Marque Recalls HHV-8 Reagent Due to Export Labeling Error

    Cell Marque is recalling HHV-8 in vitro diagnostic reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2212-2017·2017-06-07

    Acumedia Sabouraud Dextrose Agar Recalled for Incorrect Storage Labeling

    Acumedia is recalling 10 units of Sabouraud Dextrose Agar in Illinois due to incorrect storage temperature information on the label.

    Product
    Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2203-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling

    Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.

    Product
    Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2208-2017·2017-06-07

    Cell Marque Recalls Varicella Zoster Virus Reagent Due to Labeling Error

    Cell Marque is recalling Varicella Zoster Virus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2204-2017·2017-06-07

    Cell Marque Recalls Her2/Neu Reagents for Missing Export Labeling

    Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2205-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus I Reagents Due to Labeling Error

    Cell Marque is recalling Herpes Simplex Virus I reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2201-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling 8 units of Estrogen Receptor reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2202-2017·2017-06-07

    Cell Marque Recalls H. pylori Reagent Due to Missing Export Labeling

    Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2207-2017·2017-06-07

    Cell Marque Recalls SV40 Reagent Due to Missing Export Labeling

    Cell Marque is recalling three units of SV40 (MRQ-4) reagent because they were not labeled 'For Export Only' as required by law.

    Product
    SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2168-2017·2017-06-07

    Tosoh AIA-PACK TPOAb Control Set Recalled for Labeling Errors

    Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.

    Product
    AIA-PACK TPOAb CONTROL SET
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-2199-2017·2017-06-07

    Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error

    Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.

    Product
    Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2214-2017·2017-06-07

    Acumedia Recalls Beef Extract Powder Due to Incorrect Expiration Date

    Acumedia Manufacturers, Inc. is recalling 16 units of Beef Extract Powder (PN 7228) because the label displays an incorrect expiration date.

    Product
    Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2167-2017·2017-06-07

    Randox Liquid Urine Control Level 3 Recalled for Labeling Error

    Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3 due to a labeling error affecting Total Protein values.

    Product
    Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
    Category
    Medical Device
    Distribution
    1 state