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.

17826–17850 of 21645

  • ModerateFDA (Devices)·Z-2631-2014·2014-09-24

    Fresenius Recalls BD Vacutainer SST Tubes for Improper Storage Temperature

    Fresenius Medical Care is recalling 9 boxes of BD Vacutainer SST Tubes held at improper storage temperatures. The tubes were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2471-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Belgian Milk Chocolate Frozen Desserts

    Jenis Splendid Ice Creams LLC is recalling Belgian Milk Chocolate frozen desserts because the labels do not list ingredients.

    Product
    Belgian Milk Chocolate- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2460-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Cucumber Granita for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Cucumber Granita because the frozen dessert packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Cucumber Granita- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2639-2014·2014-09-24

    Amerx Recalls Amergel Hydrogel Gauze Dressing for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amergel Hydrogel Saturated Gauze Dressing pads because the product labeling includes unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2469-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Pumpkin 5 Spice Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Pumpkin 5 Spice frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Pumpkin 5 spice- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2632-2014·2014-09-24

    Fresenius Recalls BD Vacutainer Trace Element Tubes Due to Storage Issues

    Fresenius Medical Care is recalling specific BD Vacutainer Trace Element Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2641-2014·2014-09-24

    Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amerigel Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.

    Product
    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2669-2014·2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2480-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Sweet Corn with Blackberry frozen desserts because the packaging does not list ingredients.

    Product
    Sweet Corn with Blackberry- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2459-2014·2014-09-24

    Jenis Creme Fraiche Frozen Dessert Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Creme Fraiche frozen dessert because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Creme Fraiche- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2478-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Sweet Basil with Honey Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Sweet Basil with Honey frozen dessert because the product labeling does not include an ingredients list.

    Product
    Sweet Basil with Honey- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2475-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Star Anise Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Star Anise with Candied Fennel frozen dessert because the packaging does not list ingredients.

    Product
    Star Anise with Candied Fennel- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2470-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Root Beer Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Root Beer frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2451-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Apple Cider Sorbet for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Apple Cider Sorbet because the frozen dessert packaging does not list ingredients.

    Product
    Apple Cider Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2634-2014·2014-09-24

    Fresenius Recalls BD Vacutainer PST Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling BD Vacutainer PST Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2476-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Strawberry Rose Petal Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Strawberry Rose Petal frozen dessert because the product labeling does not include ingredients.

    Product
    Strawberry Rose Petal- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2472-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Saigon Cinnamon Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Saigon Cinnamon frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2649-2014·2014-09-24

    Siemens Axiom Luminos dRF Recalled for Fluid Infiltration Malfunction Risk

    Siemens is recalling 33 Axiom Luminos dRF systems because fluid exposure to the tableside control panel may cause a malfunction and automatic shutdown.

    Product
    AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2462-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Dark Cocoa Smoked Almond frozen desserts because the packaging does not list ingredients.

    Product
    Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1585-2014·2014-09-24

    Solace International Recalls Dermatend Original for Unapproved Labeling Claims

    Solace International is recalling Dermatend Original mole and wart remover because the label contains unapproved claims. The product is not FDA approved.

    Product
    Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1586-2014·2014-09-24

    Solace International Recalls Dermatend Ultra for Unapproved Labeling Claims

    Solace International Inc. is recalling Dermatend Ultra skin tag remover because the product labeling contains unapproved claims and the product is not FDA approved.

    Product
    Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2479-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Torrone Frozen Dessert for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Torrone frozen dessert because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2461-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Dark Cocoa Peppermint Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Dark Cocoa Peppermint frozen dessert because the product labeling does not include ingredients.

    Product
    Dark Cocoa Peppermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2629-2014·2014-09-24

    Fresenius Recalls BD Vacutainer Serum Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling 3 boxes of BD Vacutainer Serum Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states