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.

8951–8975 of 21595

  • ModerateFDA (Food)·F-1415-2019·2019-06-05

    Oakhouse Bakery Recalls GreenWise Cranberry Cashew Granola Due to Foreign Material

    Oakhouse Bakery is recalling GreenWise Cranberry Cashew Granola because it may contain pieces of foreign material. The product was distributed in Arkansas and Colorado.

    Product
    GreenWise Cranberry Cashew Granola, Net Wt. 12 oz. (340g) Re-sealable Pouch. UPC 41415-18305. Made with organic oats. Distributed by Publix Super Markets, Inc., Lakeland, FL 33802.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1424-2019·2019-06-05

    Dole Classic Coleslaw Recalled Due to Soft Plastic Contamination

    Dole Fresh Vegetables is recalling 6,255 cases of Classic Coleslaw (US) because of complaints regarding irregular pieces of soft plastic found in the product.

    Product
    Dole Classic Coleslaw (US) Shredded cabbage and carrots. 14 oz. US
    Category
    Food
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1314-2019·2019-06-05

    Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

    Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.

    Product
    INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1310-2019·2019-06-05

    Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.

    Product
    ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1408-2019·2019-06-05

    Oakhouse Bakery Recalls Coconut Cashew Granola for Foreign Material

    Oakhouse Bakery is recalling purely elizabeth Coconut Cashew Grain-Free Granola because it may contain pieces of foreign material.

    Product
    purely elizabeth Coconut Cashew Grain-Free Granola, packaged in Net Wt. 8 oz. (227g) Re-sealable Pouch, UPC 55140-00270, and Net Wt. 16 oz. (1LB) Re-sealable Pouch, UPC 55140-00294. Made with organic hemp, chia, and coconut flakes. Distributed By: Purely Elizabeth, LLC, Bould
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1416-2019·2019-06-05

    Oakhouse Bakery Recalls GreenWise Granola for Foreign Material

    Oakhouse Bakery is recalling GreenWise Cinnamon Peanut Butter Grain-Free Granola because it may contain pieces of foreign material.

    Product
    GreenWise Cinnamon Peanut Butter Grain-Free Granola, Net Wt. 8 oz. (226g) Re-sealable Pouch. UPC 41415-18005. Made with organic sunflower seeds, organic pumpkin seeds, and organic coconut flakes. Distributed by Publix Super Markets, Inc., Lakeland, FL 33802.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1688-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1414-2019·2019-06-05

    Oakhouse Bakery Recalls Pumpkin Spice Granola for Foreign Material

    Oakhouse Bakery is recalling 2,545 cases of purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola because the product may contain pieces of foreign material.

    Product
    purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 10589-03015. made with organic chia, dodonut flakes and ashwagandha. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1318-2019·2019-06-05

    Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2019·2019-06-05

    K2M Fenestrated Taps Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.

    Product
    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration tech
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1681-2019·2019-06-05

    King LTS-D Kit Size 1 Recalled for Incorrect Packaging and Labeling

    King Systems Corp. dba Ambu, Inc. is recalling 270 King LTS-D Kit Size 1 units because they were incorrectly packaged and labeled as size 1 products.

    Product
    King LTS-D Kit Size 1, Model Number KLTSD431
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1319-2019·2019-06-05

    Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations

    Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.

    Product
    Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 N
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1410-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Banana Nut Butter Bars

    Oakhouse Bakery is recalling Purely Elizabeth Banana Nut Butter Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Banana Nut Butter Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00209. Display Carton UPC 10589-03005. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1413-2019·2019-06-05

    Oakhouse Bakery Recalls Coconut Cashew Grain-Free Bars Due to Foreign Material

    Oakhouse Bakery is recalling purely elizabeth Coconut Cashew Grain-Free Bars because they may contain pieces of foreign material.

    Product
    purely elizabeth Coconut Cashew Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00213. Display Carton UPC 10589-03007. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1317-2019·2019-06-05

    Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.

    Product
    Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2019·2019-06-05

    Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations

    Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.

    Product
    Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1411-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Chocolate Sea Salt Grain-Free Bars

    Oakhouse Bakery is recalling Purely Elizabeth Chocolate Sea Salt Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Chocolate Sea Salt Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00208. Display Carton UPC 10589-03006. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1409-2019·2019-06-05

    Oakhouse Bakery Recalls Granola for Potential Foreign Material Contamination

    Oakhouse Bakery is recalling purely elizabeth Banana Nut Butter Grain-Free Granola because it may contain pieces of foreign material.

    Product
    purely elizabeth Banana Nut Butter Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 55140-00272. Made with organic hemp, chia, and coconut flakes. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1403-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1404-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the applicable specifications.

    Product
    Drill, cannulated, 4x150mm, AO, Item Number 502015403
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1483-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills that may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1405-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide