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.

31976–32000 of 50502

  • HighFDA (Devices)·Z-2591-2017·2017-06-21

    Merge Healthcare Recalls Merge PACS Software Due to Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram-Negative Identification Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram-Negative identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2017·2017-06-21

    Biomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2359-2017·2017-06-21

    Bright Farms Spring Mix Recalled Due to Metal Contamination

    Bright Farms is recalling Spring Mix salad products in 4 oz. and 8 oz. packages because metal was detected in the product.

    Product
    Bright Farms Spring Mix (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2337-2017·2017-06-21

    Arrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access

    Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.

    Product
    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2017·2017-06-21

    Monica Novii Wireless Patch System Recalled for Battery Damage and Heat

    Monica Healthcare Ltd is recalling the Monica Novii Wireless Patch System due to potential battery damage and excess heat from prolonged charging.

    Product
    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2501-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2017·2017-06-21

    Arrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues

    Arrow International is recalling single-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2369-2017·2017-06-21

    General Mills Recalls Chocolate Chip Cookie Dough Larabars Due to Packaging Error

    General Mills is recalling chocolate chip cookie dough Larabars that were incorrectly packaged in peanut butter cookie boxes. The product contains cashews, which are not listed on the peanut butter box label.

    Product
    Chocolate chip cookie dough larabars, 10 count , UPC 100-21908-49031 incorrectly packaged in peanut butter cookie larabars boxes, 10 count, UPC000-21908-49154.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2322-2017·2017-06-21

    Philips DuraDiagnost X-ray systems recalled for cracked welding joints

    Philips is recalling 98 DuraDiagnost X-ray systems because the tube arm assembly could fall due to cracked welding joints.

    Product
    Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2393-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2336-2017·2017-06-21

    Arrow Multi-Lumen CVC Kit Recalled by FDA for Medical Device Safety

    Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.

    Product
    Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2370-2017·2017-06-21

    Woodland Foods Recalls Birdseye Chiles Due to Undeclared Peanut

    Woodland Foods is recalling D'Allesandro De-stemmed Birdseye Chiles because trace amounts of undeclared peanut were found in the product.

    Product
    D'Allesandro Woodland Foods De-stemmed Birdseye Chiles 1, 5, and 35 lbs., food service, bag in box container, singe unit per case.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2371-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide