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.

7201–7225 of 21595

  • ModerateFDA (Devices)·Z-1607-2020·2020-04-08

    Trilliant Surgical Twist Sublatar Implant System Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Twist Sublatar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1608-2020·2020-04-08

    Trilliant Surgical Disco Subtalar Implant Instructions for Use Recall

    Trilliant Surgical, LLC is recalling Instructions for Use and Surgical Cleaning and Sterilization Protocols for the Disco Subtalar Implant System to update dry time parameters.

    Product
    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1624-2020·2020-04-08

    Gentell Hydrogel Ag Gauze Recalled for FDA Registration Deficiency

    Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4 gauze because the product was not properly registered with the FDA.

    Product
    Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2020·2020-04-08

    Butterfly iQ Ultrasound System Recalled for Lack of FDA Approval

    Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).

    Product
    Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0866-2020·2020-04-08

    NutraBlend Russian Bear Weight Gainer Recalled for Undeclared Soy

    NutraBlend Foods is recalling Russian Bear 10000 Weight Gainer Formula Vanilla due to undeclared soy protein isolate. The product was distributed to one customer in Canada.

    Product
    Russian Bear 10000 Weight Gainer Formula Vanilla packed in 15lb bags
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0862-2020·2020-04-01

    American Classic Snack Company Recalls Sweet Bourbon Crunchers Pretzels

    American Classic Snack Company is recalling Sweet Bourbon Crunchers Pretzels because they are improperly labeled with a gluten-free claim.

    Product
    American Classic Snack Company Sweet Bourbon Crunchers Pretzels in 8 oz. bags, 12 bags per case.
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Food)·F-0849-2020·2020-04-01

    Proxy Foods Recalls Green Pozole Soup Starter Due to Missing Records

    Proxy Foods LLC is recalling Green Pozole Soup Starter because the company is missing processing records and production logs for the product.

    Product
    Green Pozole Soup Starter, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). or 24 fl. oz. 16 fl oz UPC 738283379116 24 fl oz UPC 860322002218 The label is read in parts: "***GREEN POZOLE SOUP STARTER ***INGREDIENTS: Water, Hominy, Tomatillo, Po
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1597-2020·2020-04-01

    Elekta MOSAIQ Oncology Software Recalled for Unit Labeling Error

    Elekta Impac Software is recalling MOSAIQ oncology software because users may enter metric values into fields labeled with US standard units.

    Product
    MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0850-2020·2020-04-01

    Proxy Foods Recalls White Corn Hominy Due to Missing Production Records

    Proxy Foods LLC is recalling 96 jars of White Corn Hominy in Oregon and Washington because production logs are missing.

    Product
    White Corn Hominy, Pozole To The People, packaged in glass jars. Net Wt. 16 fl. oz., (473.2 mL). UPC 738283379147. The label is read in parts: "***WHITE CORN HOMINY ***INGREDIENTS: Water, White Corn Hominy, Sea Salt, Lime Juice ***Made by Proxy Foods, LLC 7328 SE Foster Road,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0903-2020·2020-04-01

    Springboard Green Power Recalled for Unapproved Herbicide Contamination

    Organic By Nature, Inc. is recalling Springboard Green Power dietary supplements because the flaxseed ingredient contains an unapproved herbicide.

    Product
    Springboard Green Power, Dietary Supplement; 240g Plastic Bottle; Finished Product Item# FSBPGO240G Springboard, Spring Valley, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2020·2020-04-01

    Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference

    Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high results for patients taking eltrombopag.

    Product
    Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2020·2020-04-01

    Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate high results for patients taking eltrombopag.

    Product
    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2020·2020-04-01

    Fresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems

    Fresenius Medical Care is recalling 3,561 Honeywell pressure transducers used in hemodialysis delivery systems due to lower long-term reliability.

    Product
    Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1062-2020·2020-04-01

    Jubilant Draximage Recalls DRAXIMAGE DTPA Kits Due to Stability Failures

    Jubilant Draximage is recalling DRAXIMAGE DTPA kits because they failed stability specifications. The affected product was distributed throughout the United States.

    Product
    DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1066-2020·2020-04-01

    Advil Liqui-Gel Minis Recalled for Missing Safety Warnings

    Glaxosmithkline is recalling 446,628 bottles of Advil Liqui-Gel Minis because certain lots lack required safety warning information in the Drug Facts Panel.

    Product
    ADVIL — ADVIL (IBUPROFEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1534-2020·2020-04-01

    bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals

    bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.

    Product
    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0906-2020·2020-04-01

    Organic Super Protein Vanilla Coconut Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Touchstone Essentials Organic Super Protein Vanilla Coconut due to unapproved herbicide Haloxyfop in the flaxseed ingredient.

    Product
    Touchstone Essentials Organic Super Protein Vanilla Coconut; Whole Food Dietary Supplement; Net Wt. 18.3 oz. (520g) Plastic Bottle; Finished Product Item#: FTEVPVC520G Manufactured Exclusively for: Touchstone Essentials, Raleigh, NC
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1538-2020·2020-04-01

    Siemens ADVIA Chemistry Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in patients taking eltrombopag.

    Product
    ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0904-2020·2020-04-01

    Pure Planet Organic Parasite Cleanse Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Pure Planet Organic Parasite Cleanse because the flaxseed powder ingredient contains the unapproved herbicide Haloxyfop.

    Product
    Pure Planet Organic Parasite Cleanse; Net Wt. 174g Glass Jar; Finished Product Item # 52700 Manufactured and Distributed by: Pure Planet, Rancho Dominguez, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1552-2020·2020-04-01

    Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error

    Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.

    Product
    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
    Category
    Medical Device
    Distribution
    19 states