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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26726–26750 of 40357

  • 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
  • LowFDA (Devices)·Z-2200-2017·2017-06-07

    Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling

    Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.

    Product
    Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2206-2017·2017-06-07

    Cell Marque Recalls Herpes Simplex Virus II Reagents for Labeling Errors

    Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.

    Product
    Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2213-2017·2017-06-07

    Acumedia Nutrient Gelatin Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers recalled 5 units of Nutrient Gelatin because the label displayed an incorrect expiration date.

    Product
    Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2119-2017·2017-05-31

    EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity

    EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.

    Product
    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2052-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2051-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall

    St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2053-2017·2017-05-31

    St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update

    St. Jude Medical is providing software and hardware updates to HeartMate II LVAS Pocket Controllers to facilitate the exchange to a backup controller.

    Product
    HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2118-2017·2017-05-31

    EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity

    EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.

    Product
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

    Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

    Product
    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2017·2017-05-31

    Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns

    Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.

    Product
    Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide