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.

12926–12950 of 21617

  • ModerateFDA (Drugs)·D-0662-2017·2017-04-19

    Signature Club A Recalls Double Hyaluronic 1000 Day Cream for Microbial Contamination

    Signature Club A Ltd is recalling 1,237 jars of Double Hyaluronic 1000 Volumizing Day Cream due to microbial contamination.

    Product
    Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1885-2017·2017-04-19

    Vegetarian Tuna Fish Recalled for Undeclared Wheat Allergen

    Companion Foods Corp. is recalling Vegetarian Tuna Fish cans because an FDA inspection found wheat was not properly declared in the ingredient list.

    Product
    VEGETARIAN TUNA FISH, 5 1/3 oz.. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10500 1 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1803-2017·2017-04-19

    FDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims

    2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Lower Back Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1775-2017·2017-04-19

    Volcano Recalls Refinity Rotational Intravascular Ultrasound Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Rotational Intravascular Ultrasound Catheters because high complaint rates indicate kinking near the proximal shaft, which could disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1771-2017·2017-04-19

    Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Sizing Error

    Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance Peripheral Guide Wires because they may contain the wrong size product.

    Product
    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2017·2017-04-19

    Windstone Medical Recalls Lasik Trays Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 260 Lasik Tray kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2017·2017-04-19

    Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.

    Product
    MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2017·2017-04-19

    2k Innovations Recalls Volt Resistance Frostie Heated Gloves for Unapproved Claims

    2k Innovations Inc. is recalling Volt Resistance Frostie Heated Gloves because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2017·2017-04-19

    2k Innovations Recalls Volt Heated Elbow Garments for Unapproved Claims

    2k Innovations is recalling 22,757 Volt Resistance Heated Elbow Garments because FDA inspections found the firm made unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0665-2017·2017-04-19

    Medisca Recalls Estradiol API Due to cGMP Deviations

    Medisca, Inc. is recalling Estradiol, USP (Hemihydrate) (Micronized) API products due to cGMP deviations identified during a recent FDA inspection.

    Product
    ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1810-2017·2017-04-19

    FDA Recalls Volt Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Slippers because FDA inspections found the product makes unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1812-2017·2017-04-19

    FDA Recalls Volt Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Slippers because the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2017·2017-04-19

    FDA Recalls Volt Heated Knee Wrap for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Therapy Knee Wraps because FDA inspections found the product makes unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1900-2017·2017-04-19

    Good Plenty Supreme Abalone Noodles Recalled for Undeclared Wheat

    Lian Hwa Foods is recalling Good Plenty Supreme Abalone Noodles because wheat was not properly declared on the label.

    Product
    Good Plenty Brand Supreme Abalone Noodles, 21.2 oz. box. Each box contains Retort pouch of Noodles and Abalone. These two pouches are packed together in the box; 10 boxes per case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1797-2017·2017-04-19

    Windstone Medical Recalls PRK Trays Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 20 PRK kits because the sterile packaging of the included eye pads may be compromised.

    Product
    PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1882-2017·2017-04-19

    Companion Foods Recalls Fat-Choy Style Vegetable Soup for Wheat Mislabeling

    Companion Foods Corp. is recalling Fat-Choy Style Vegetable Soup because an FDA inspection found wheat was not properly declared in the ingredient list, despite being listed in the Contains statement.

    Product
    FAT-CHOY STYLE VEGETABLE SOUP, 15 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 076277 10960 9 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1818-2017·2017-04-19

    Keystone Dental Recalls PrimaConnex Straight Implants Due to Mislabeling

    Keystone Dental Inc. is recalling 59 PrimaConnex Straight Implants because they were incorrectly labeled as Tapered Implants.

    Product
    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1813-2017·2017-04-19

    FDA Recalls Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Unisex Rechargeable Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims.

    Product
    Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1954-2017·2017-04-19

    Myers Cider Mill Recalls Apple Cider Due to Process Deviation

    Myers Cider Mill LLC is voluntarily recalling 100% Apple Cider due to a process deviation. The product was sold in Ohio.

    Product
    100% APPLE CIDER 1 Gallon (3.78L) UV TESTED KEEP REFRIGERATED UPC 0 85591 00128 1
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1789-2017·2017-04-19

    Windstone ENT Pack Recall Due to Compromised Sterile Packaging

    Windstone Medical Packaging is recalling 16 ENT kits because the sterile packaging of the included Medtronic eye pads may be compromised.

    Product
    ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0656-2017·2017-04-19

    FDA Recalls Estriol Micronized Bulk Drug Due to Quality Assurance Failures

    Qinhuangdao Zizhu Pharmaceutical is recalling bulk Estriol Micronized, USP, due to cGMP deviations and lack of quality assurance. The product is distributed to pharmacies in six states for prescription compounding.

    Product
    Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
    Category
    Drug
    Distribution
    6 states
  • ModerateNHTSA·17V256000·2017-04-18

    Honda Recalls 2017 CR-V and Acura RDX for Fading Certification Labels

    Honda is recalling 2017 CR-V and Acura RDX vehicles because certification labels may wipe away with alcohol solvents, potentially leading to vehicle overload.

    Product
    ACURA — ACURA, HONDA RDX, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0635-2017·2017-04-12

    Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination

    Alvogen, Inc. is recalling Adalat CC (nifedipine) 90 mg extended-release tablets because residual sorafenib powder was found in the manufacturing equipment's inlet air duct.

    Product
    Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1863-2017·2017-04-12

    McShare's Inc Recalls Premix Premix Due to Undeclared Soy

    McShare's Inc is recalling 700 lbs of Premack HS Vitamin RDA Premix because it contains low levels of undeclared soy.

    Product
    Premark HS Vitamin RDA Premix, Net Wt. 50 lbs., Item No. 136375.
    Category
    Food
    Distribution
    2 states