The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

39476–39500 of 50506

  • HighFDA (Devices)·Z-1155-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 489 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1144-2015·2015-03-04

    Spacelabs XPREZZON Bedside Monitors Recalled for Boot Failure

    Spacelabs Healthcare is recalling XPREZZON Bedside Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1182-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 11 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

    Navilyst Medical is recalling 454 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1359-2015·2015-03-04

    Gulf Coast Seasoned Flour Recalled for Possible Peanut Protein

    Gulf Coast Blenders is recalling Metairie Country Club Seasoned Flour because it contains ground cumin that may have peanut protein.

    Product
    GULF COAST BRAND METAIRIE COUNTRY CLUB SEASONED FLOUR, NET WEIGHT 50 lbs. (22.68 kg.), GULF COAST BLENDERS, INC., 7801 Townsend Place, New Orleans, LA 70126
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1154-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 438 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 562 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1299-2015·2015-03-04

    Lime Chipotle Marinade Recalled Due to Peanut Protein Contamination

    Barhyte Specialty Foods Inc. is recalling Lime Chipotle Marinade due to peanut protein contamination. Consumers should stop using the product.

    Product
    Pacific Coast Selections Lime Chipotle Marinade, UPC 0 98487 10045 0; Saucy Mama Lime Chipotle Marinade, UPC 0 47281 40200 0; Product is packaged in clear, glass, 12 fluid ounce, ring neck bottle, with 38 mm black continuous thread closure covered with a black tamper evident…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1174-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2015·2015-03-04

    Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise

    Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.

    Product
    Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1192-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1297-2015·2015-03-04

    Holiday Foods Vegetable Samosa Potstickers Recalled for Undeclared Peanut Allergen

    Schwan Food Company is recalling 83 cases of Holiday Foods Vegetable Samosa Potstickers due to a potential undeclared peanut allergen.

    Product
    Holiday Foods, Hors D'Oeuvre, 4802025 Vegetable Samosa Potsticker, 100 0.7 oz PCS , Food for institutional use only.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1153-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 136 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns

    Navilyst Medical is recalling 411 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1146-2015·2015-03-04

    Biomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws

    Biomet Spine is recalling 1,999 5.5 mm rod set screws because they are out of specification. The devices are used in spinal fixation constructs.

    Product
    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1361-2015·2015-03-04

    Gulf Coast Blenders Recalls REX King of Spice Ground Pati Dry Marinade

    Gulf Coast Blenders is recalling REX King of Spice Ground Pati Dry Marinade due to possible peanut protein contamination in the ground cumin ingredient.

    Product
    REX KING OF SPICE (R) GROUND PATI DRY MARINADE, NET WEIGHT 25 lbs. (11.34kg.), Produced Exclusively for: REX FINE FOODS, New Orleans, LA 70126
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0801-2015·2015-03-04

    Pacific Fusion Frozen Tuna Steak Recalled for High Histamine Levels

    Thai Ocean Venture Co., Ltd. is recalling Pacific Fusion Frozen Tuna Steak due to high histamine levels found in FDA samples.

    Product
    Pacific Fusion Frozen Tuna Steak Wild Caught Net Weight: 15 lb (240oz) 6.80 kg Ingredients: Tuna, tasteless smoke used as a preservative to promote color retention SKU: 0 75627 14610 3 Production Date: 10 MAR 2014 Best Before: 10 MAR 2016 Manufactured By: Thai Ocean…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1202-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 74 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 30 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.

    Product
    NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns

    Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.

    Product
    NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling specific lots of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide