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.

7226–7250 of 21595

  • ModerateFDA (Devices)·Z-1544-2020·2020-04-01

    Medline Stick Sponge Presaturated W/PVP Recalled for Packaging Seal Voids

    Medline is recalling Stick Sponge Presaturated W/PVP units due to packaging seal voids that compromise sterility.

    Product
    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2020·2020-04-01

    Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2020·2020-04-01

    Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2020·2020-04-01

    Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias

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

    Product
    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1547-2020·2020-04-01

    Randox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values

    Randox Laboratories is recalling Chemistry QC Premium Plus due to incorrect Sodium target values. The error affects quality control accuracy for diagnostic assays.

    Product
    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2020·2020-04-01

    T.A.G. Medical Recalls FlipCutter III Drills Due to Sterile Barrier Risk

    T.A.G. Medical Products is recalling 6,625 FlipCutter III Drills because cracked blister trays may compromise the sterile barrier, posing a risk of particulate contamination.

    Product
    FlipCutter III Drill
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0898-2020·2020-04-01

    Organic By Nature Daily Fiber Blend Recalled for Unapproved Herbicide

    Organic By Nature is recalling Daily Fiber Blend - Caramel Apple Flavor because the flaxseed powder ingredient contains unapproved herbicide Haloxyfop.

    Product
    Daily Fiber Blend - Caramel Apple Flavor; Organic Plant Powder Mix for preparation of a fiber-rich drink, 540g Plastic Bottle, 180g Bio Bag Terra Pouch; Finished Product Item#: 2012E, 2012, 2012-P65, 2013, 2013-P65, 2016, 2016-P65 Brand names of: Platinum Health Europe, Ne
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1541-2020·2020-04-01

    Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.

    Product
    Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2020·2020-04-01

    Medtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall

    Medtronic is recalling two Open Pivot Aortic Valve Grafts because the outer box was mislabeled as Aortic while the device was Mitral.

    Product
    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0852-2020·2020-04-01

    Dean Foods Recalls Baskin Robbins Ice Cream Sandwiches for Undeclared Dyes

    Dean Foods is recalling Baskin Robbins Mint Chocolate Chip Ice Cream Sandwiches because they contain undeclared Yellow #5 and Blue #1 dyes.

    Product
    Baskin Robbins Mint Chocolate Chip, Ice Cream Sandwiches with Mint Ice Cream, Semi-Sweet Chocolate Chips & Chocolate Wafers 4 Pack; 4 3.5 FL OZ (104 mL) Sandwiches /14 FL OZ (414 mL)
    Category
    Food
    Distribution
    7 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 (Drugs)·D-1068-2020·2020-04-01

    GlaxoSmithKline Recalls Advil Allergy and Congestion Relief for Missing Warnings

    GlaxoSmithKline is recalling specific lots of Advil Allergy and Congestion Relief because the Drug Facts Panel lacks required safety warning information.

    Product
    Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
    Category
    Drug
    Distribution
    1 state
  • 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 (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 (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 (Drugs)·D-1060-2020·2020-04-01

    Nystatin Oral Suspension Recalled for Low Potency

    Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it tested below the required potency level.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    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 (Devices)·Z-1566-2020·2020-04-01

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Spectrum Central Venous Catheter Trays because the printed expiration dates are incorrect. The devices were distributed to seven US states and Canada.

    Product
    Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0893-2020·2020-04-01

    Alkamind Creamy Chocolate Protein Recalled for Unapproved Herbicide

    Organic By Nature, Inc. is recalling Alkamind Creamy Chocolate Organic Daily Protein due to the presence of unapproved herbicide Haloxyfop in the flaxseed powder ingredient.

    Product
    Alkamind Creamy Chocolate Organic Daily Protein; 450g Plastic Bottle; Finished Product Item # FAMCDP450G; 3 core alkaline proteins Distributed by Alkamind LLC, New York, NY 10028
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0902-2020·2020-04-01

    Organic By Nature Recalls RAWr! Life Superfoods Due to Unapproved Herbicide

    Organic By Nature is recalling RAWr! Life Organic Superfoods because the flaxseed powder ingredient contains an unapproved herbicide.

    Product
    RAWr! Life Organic Superfoods; Dietary Supplement; 300g Plastic Bottle (10.60 oz.); Finished Product Item # FHEEG300G Rawr! Life, Glendale, AZ 85308
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1065-2020·2020-04-01

    Advil Allergy and Congestion Relief Recalled for Missing Safety Warnings

    Glaxosmithkline is recalling specific lots of Advil Allergy and Congestion Relief tablets because they lack required safety warning information in the Drug Facts Panel.

    Product
    ADVIL ALLERGY AND CONGESTION RELIEF — ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0848-2020·2020-04-01

    Proxy Foods Recalls Red Pozole Soup Starter Due to Missing Records

    Proxy Foods LLC is recalling Red Pozole Soup Starter because of missing production logs and observations of swollen or leaking jars.

    Product
    Red 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 738283379109 24 fl oz UPC 860322002201 The label is read in parts: "***RED POZOLE SOUP STARTER ***NET WT. 24 OZ. ***INGREDIENTS: Water, Hominy,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1599-2020·2020-04-01

    Siemens Atellica CH Ethyl Alcohol Assay Recalled for Calibration Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Ethyl Alcohol assays due to potential positive bias in results within the 10-day calibration interval.

    Product
    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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