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.

6076–6100 of 21595

  • 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-1092-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Defects

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

    Product
    Lab Coats SMS Medium White, SKU 2301LC 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 mat
    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-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-1078-2021·2021-02-17

    Cardinal Health Recalls Chemo Spill Kits Due to Gown Defects

    Cardinal Health is recalling 137,346 ChemoPlus Chemo Spill Kits because the included gowns may have rips, holes, or foreign material.

    Product
    Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes

    Cardinal Health is recalling isolation gowns and lab coats because they may have rips, holes, or open seams that compromise barrier protection.

    Product
    Gown Isolation W/Ties Xl Ylw, SKU 1101PG 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 (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-0942-2021·2021-02-10

    Fresenius Medical Care Recalls NaturaLyte Liquid Acid Concentrate Due to Missing Labels

    Fresenius Medical Care is recalling 2,280 cases of NaturaLyte Liquid Acid concentrate because bottles are missing product labels.

    Product
    Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2021·2021-02-10

    Allergan Recalls Refresh Contacts Comfort Drops Due to Missing Instructions

    Allergan PLC is recalling Refresh Contacts Contact Lens Comfort Drops because the packages are missing the Instruction For Use insert. Consumers should stop using the product and contact the manufacturer.

    Product
    REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0245-2021·2021-02-10

    Lake Champlain Chocolates Recalls Gift Baskets for Plastic Contamination

    Champlain Chocolate Company is recalling Lake Champlain Chocolates gift baskets because they may contain plastic pieces.

    Product
    Lake Champlain Chocolates - gift basket- BE MINE; Net Wt. 2lbs.; UPC: 76993305237 Gift basket contains the following items: 21 piece Grand Valentine Chocolate Heart Assortment " 1 3oz Organic 57% Dark Chocolate Bar " 1 3 oz Raspberries and Dark Chocolate Bar " 1 1.9oz Fru
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0243-2021·2021-02-10

    Amy's Golden Lentil Indian Dal Soup Recalled for Egg Contamination

    Amy's Kitchen is recalling Golden Lentil Indian Dal soup because Canadian testing detected 1.4 ppm of egg, despite the product not listing egg as an ingredient.

    Product
    Amy's Soups made with organic Lentils - Golden Lentil - Indian Dal. Net Wt. 14.4 oz (408g) Ready to serve - do not add water Ingredient: Filtered water, Organic Yellow Split Peas, Organic Red Lentils, Organic Carrots, Organic Tomato Puree, Organic Extra Virgin Olive Oil, Sha
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Food)·F-0269-2021·2021-02-10

    Nongshim Shin Ramyun Recalled for Metal Shavings in California

    Nongshim America is recalling Shin Ramyun sold in California due to the presence of small metal shavings in the product.

    Product
    Nongshim brand Shin Ramyun; Sold in the following packaging configurations: 4.2 oz, individual bags UPC 031146150601 16 count box (16 x 4.2 oz. pkgs.) UPC 031146022854 10 count box (10 x 4.2 oz. pkgs.) UPC 00031146023981
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0934-2021·2021-02-10

    Brainreader Recalls Neuroreader Software Due to Database Discrepancy

    Brainreader ApS is recalling Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference database different from the FDA-cleared version.

    Product
    Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2021·2021-02-10

    Smith & Nephew Recalls Versabond AB Bone Cement Due to Heat Exposure

    Smith & Nephew is recalling 5,190 units of Versabond AB bone cement due to potential heat and humidity exposure that altered the product's consistency.

    Product
    VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0247-2021·2021-02-10

    Chocolates of Vermont Recalled for Potential Plastic Contamination

    Champlain Chocolate Company is recalling specific lots of Chocolates of Vermont products because they may contain plastic pieces.

    Product
    Chocolates of Vermont 1.Lake Champlain Chocolates - Chocolates of Vermont - Assorted Bulk 2.5 lbs. - Online Stock code: 1Y302-000000-1 UPC: 76993305399 2. Lake Champlain Chocolates - Chocolates of Vermont - 4 Piece Sampler - 1.9 oz.- Online Stock Code -1Y302-004001-1 UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0923-2021·2021-02-03

    BD Stimex Insulated Needle Recall for Missing Contraindications

    Becton Dickinson is recalling BD Stimex Insulated Needles because the instructions for use lack general contraindications.

    Product
    BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0931-2021·2021-02-03

    Yukon polyaxial screw component recalled for incorrect laser marking

    The Yukon polyaxial screw component in the Yukon Spinal System was recalled because it was incorrectly laser marked with wrong dimensions.

    Product
    Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2021·2021-02-03

    B. Braun Introcan IV Safety Catheters Recalled for Lack of FDA Approval

    Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products do not have FDA approval for sale in the United States.

    Product
    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0727-2021·2021-02-03

    Philips ProxiDiagnost N90 X-ray System Recalled for Software Lock-in Defect

    Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.

    Product
    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0228-2021·2021-02-03

    Gem City Fine Foods Recalls Vegan Chocolate Cake Due to Mislabeled Nutrition Facts

    Gem City Fine Foods is recalling 164 Vegan Chocolate Cakes because the nutrition facts panel and ingredient list were incorrect.

    Product
    Vegan Chocolate Cake, 25 oz., packaged in plastic base/cake dome, UPC 855026001421, Gem City Fine Foods, www.gemcityfinefoods.com. Keep Frozen.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0929-2021·2021-02-03

    Neocis Anterior Chairside Splints Recalled for Potential Mislabeling

    Neocis, Inc. is recalling 100 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected units were distributed to facilities in seven states.

    Product
    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0918-2021·2021-02-03

    Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors

    Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.

    Product
    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0924-2021·2021-02-03

    BD Regional Block Needles Recalled for Missing Contraindications in Instructions

    Becton Dickinson is recalling BD Regional Block Needles because the instructions for use lack general contraindications, as advised by the European Notified Body.

    Product
    BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
    Category
    Medical Device
    Distribution
    18 states