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.

24701–24725 of 50442

  • HighFDA (Food)·F-0033-2020·2019-10-16

    Vinh Sanh Trading Corp Recalls Tep Say Crispy Tiny Shrimp Snack

    Vinh Sanh Trading Corp is recalling Tep Say Crispy Tiny Shrimp Snack due to undeclared sulfites. The product was distributed to 19 U.S. states.

    Product
    Tep Say Crispy Tiny Shrimp Snack, Net Wt. 7 oz. in plastic jar UPC 7 37483 77926 9 Distributed By: First World Trading Corp. Fremont, California Tel: (510) 683-8778
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0054-2020·2019-10-16

    Becton Dickinson Recalls BD Microtainer Z Tubes Due to Damaged Reservoirs

    Becton Dickinson & Company is recalling BD Microtainer Z No Additive Tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE, 20CM, 3L, PI ECVC5120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2020·2019-10-16

    GE Healthcare Recalls AIR Technology Anterior Array MRI Coils

    GE Healthcare is recalling 22 AIR Technology Anterior Array MRI coils because the outer seam may separate, exposing porous internal material that cannot be disinfected.

    Product
    AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2020·2019-10-16

    Centurion Neonatal Procedure Tray Recall Due to Connector Fluid Droplet Risk

    Centurion Medical Products is recalling Neonatal Procedure Tray PICC Catheters because the included BD MaxZeroNeedleess Connector may release fluid droplets when disconnected.

    Product
    NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2020·2019-10-16

    Centurion Medical CVC Safety Bundle Recalled for Connector Fluid Leakage

    Centurion Medical Products is recalling CVC Triple Lumen Safety Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0021-2020·2019-10-16

    Ritter Sport KAFFEESPLITTER Chocolate Recalled for Undeclared Milk

    STARK INC. is recalling Ritter Sport KAFFEESPLITTER chocolate bars because they contain undeclared milk, a major food allergen.

    Product
    Ritter Sport KAFFEESPLITTER Chocolate with caramelized coffee beans; Net Weight: 3.5oz / 100g; Ingredients: sugar, cocoa mass, caramelized pieces of coffee beans (sugar, coffee (roasted) (4%), sunflower oil), cocoa butter, butter pure fat, emulsifier: lecithin (soy) May contain…
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0119-2020·2019-10-16

    Horiba ABX Pentra Lipase CP Analyzer Recall for Interference

    Horiba Instruments is recalling ABX Pentra Lipase CP analyzers because triglyceride and cholesterol interference may cause false abnormal lipase results.

    Product
    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0121-2020·2019-10-16

    Centurion CIRCLAMP Recall Due to Angle Mismatch Defect

    Centurion Medical Products is recalling 204 units of the CIRCLAMP W/1.3 CM BELL because a design mismatch may cause the clamp to remove foreskin without a scalpel.

    Product
    Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2020·2019-10-16

    BD Microtainer PSTTubes with Lithium Heparin Recalled for Damaged Reservoirs

    Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0032-2020·2019-10-16

    Gridestone Cafe Swiss Style Cocoa Mix Recalled for Undeclared Soy

    Diamond Crystal Brands is recalling Gridestone Cafe Swiss Style Cocoa Mix because the product contains soy lecithin, which is not declared on the label.

    Product
    Gridestone Cafe Swiss Style Cocoa Mix, Net Wt. 32 OZ (2 lb) 907 g, Distributed by Performance Food Group, Richmond, VA packaged 12 boxes per case.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0041-2020·2019-10-16

    Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions

    Ohmeda Medical is recalling Giraffe Omnibed infant incubators because cleaning guidelines failed to prevent debris buildup, creating a potential infection risk.

    Product
    Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2020·2019-10-16

    Centurion Medical Products Recalls Sterile Cap Change Kits

    Centurion Medical Products is recalling sterile cap change kits because they include a connector that may leak fluid droplets after disconnection.

    Product
    STERILE CAP CHANGE KIT DYNDC1946B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2020·2019-10-16

    Centurion Medical Recalls Neonatal Cap Change Kits Due to Fluid Droplet Risk

    Centurion Medical Products Corporation is recalling Neonatal Cap Change Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    Neonatal Cap Change Kit DT20315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2020·2019-10-16

    Centurion Medical Central Line Bundle Recalled for Fluid Droplet Risk

    Centurion Medical is recalling central line bundles containing a BD MaxZeroNeedleess Connector due to the potential for fluid droplets to separate from the sealed surface after disconnection.

    Product
    CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0072-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 30 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0042-2020·2019-10-16

    Roche Vancomycin Test Recall Due to Inaccurate Low Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0039-2020·2019-10-16

    Aziyo BioEnvelope Surgical Mesh Recalled for Possible Suture Brittleness

    Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.

    Product
    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0038-2020·2019-10-16

    Vital Scientific V-Twin Automated Chemistry Analyzer Recall for Cooling Defect

    Vital Scientific N.V. is recalling 192 V-Twin automated chemistry analyzers because an improperly installed cooling indicator board may prevent warning signals if reagent cooling fails.

    Product
    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2020·2019-10-16

    Centurion Medical Recalls VANTEX CVC Bundles Due to Connector Defect

    Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0093-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC Bundle Multimeds containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
    Category
    Medical Device
    Distribution
    Distributed nationwide