The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

6051–6075 of 21595

  • ModerateFDA (Devices)·Z-1134-2021·2021-02-24

    SenTec Digital Monitor Recalled for Missing Isolation Transformer Requirement

    SenTec AG is recalling 15 SenTec Digital Monitors because they require an isolation transformer in home care settings to meet safety standards.

    Product
    SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0258-2021·2021-02-24

    Wilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures

    Wilshire Pharmaceuticals is recalling 2,112 bottles of Meclizine HCl 12.5 mg tablets found in Florida and Texas because they failed dissolution specifications.

    Product
    Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0298-2021·2021-02-24

    Barron County Organics Recalls Unpasteurized Mint Chocolate Chip Frozen Custard

    Barron County Organics is recalling Mint Chocolate Chip Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Mint Chocolate Chip, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0263-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to Impurity Levels

    Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0264-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0297-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard Due to Pasteurization Failure

    Barron County Organics is recalling 20 Mile Coffee Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Coffee, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0257-2021·2021-02-24

    DLC Laboratories Recalls Sulfur Ointment Jars Due to Labeling Error

    DLC Laboratories is recalling 86,297 jars of Sulfur Ointment 10% because English labels for Camphor were incorrectly applied to the product.

    Product
    Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2021·2021-02-24

    Medtronic Delta CSF Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic is recalling Delta CSF flow control valves because radiopaque markings may not be clearly visible under X-ray imaging.

    Product
    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 2512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1127-2021·2021-02-24

    Sky Medical SARS-CoV-2 Rapid Test Kits Recalled for Lack of Emergency Use Authorization

    Sky Medical Supplies and Equipments LLC is recalling 10,000 SARS-CoV-2 rapid test kits distributed in Florida and Peru because they were sold without FDA Emergency Use Authorization.

    Product
    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1081-2021·2021-02-17

    Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects

    Cardinal Health is recalling ChemoPlus Drug Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0280-2021·2021-02-17

    Renaissance Food Group Recalls Buffalo Style Chicken Sliders Due to Labeling Error

    Renaissance Food Group, LLC is recalling Buffalo Style Chicken Sliders because the product label incorrectly lists ingredients for a different item and omits soy.

    Product
    BUFFALO STYLE CHICKEN Sliders NET WT. 5OZ (141g) Ingredients: Tuna Salad*** CONTAINS: EGG, FISH (TUNA), MILK, WHEAT Distributed By Renaissance Food Group, LLC 4322 Moreland Ave. Conley, GA 30288 UPC 8 26766 15590 3
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1079-2021·2021-02-17

    Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects

    Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.

    Product
    CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2021·2021-02-17

    Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results

    Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.

    Product
    EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1082-2021·2021-02-17

    Cardinal Health Recalls Kendall Spill Kits Due to Gown Defects

    Cardinal Health is recalling Kendall Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0276-2021·2021-02-17

    Hiland Chocolate Milk Recalled for Food Grade Sanitizer Contamination

    Hiland Dairy Foods is recalling 1% Lowfat Chocolate Milk contaminated with food grade sanitizer. The product was distributed in Oklahoma and Texas.

    Product
    HIland 1% Lowfat Chocolate Milk Half Pint UPC: 72060-00156-3 packaged in a paper carton 50 cartons per case
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1094-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential defects like rips, holes, and foreign material.

    Product
    Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1106-2021·2021-02-17

    Arrow AGB+ Multi-Lumen CVC Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 1,705 kits due to a potential product code mislabeling that could cause delays or allergic reactions in sensitive patients.

    Product
    Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes

    Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body flui
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2021·2021-02-17

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.

    Product
    60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential manufacturing defects such as rips, holes, and foreign material.

    Product
    Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1097-2021·2021-02-17

    Cardinal Health Recalls Kendall Blue XXL Gowns Due to Defects

    Cardinal Health is recalling Kendall Blue XXL gowns due to potential rips, holes, or foreign material that may compromise barrier protection.

    Product
    Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1099-2021·2021-02-17

    Cytocell Recalls Aquarius CRLF2 Distal Probe Due to Faint Signal Risk

    Cytocell Ltd. is recalling 72 units of the Aquarius LPH 511-A CRLF2 Distal Probe Green because faint additional signals may cause normal samples to be misreported as abnormal.

    Product
    Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1083-2021·2021-02-17

    Cardinal Health Recalls ChemoPlus Chemo Prep and Admin Kits

    Cardinal Health is recalling ChemoPlus Chemo Prep & Admin Kits because the included gowns may have defects like rips, holes, or foreign material.

    Product
    ChemoPlus" Chemo Prep & Admin Kit, CT4025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1089-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material that may compromise barrier protection.

    Product
    Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate mater
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2021·2021-02-17

    Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects

    Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.

    Product
    Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material
    Category
    Medical Device
    Distribution
    Distributed nationwide