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.

12576–12600 of 21617

  • ModerateFDA (Devices)·Z-2401-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N223), REF 413110, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2353-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Intramedullary Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling sterile intramedullary femoral stems and accessories because packaging design verification tests failed. The action covers 9,867 units distributed worldwide.

    Product
    Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2435-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 pellets distributed nationwide.

    Product
    Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2017·2017-06-14

    Spectrum Laboratory Estradiol API Recalled for CGMP Deviations

    Spectrum Laboratory Products is recalling Estradiol active pharmaceutical ingredient due to Good Manufacturing Practice deviations found during an FDA inspection.

    Product
    Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2017·2017-06-14

    Cook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions

    Cook Medical is voluntarily recalling LapSac Introducers because the reprocessing instructions do not provide sufficient detailed information for cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2017·2017-06-14

    Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

    Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

    Product
    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2017·2017-06-14

    Nexstim eXima NBS System Software Recalled for File Duplication Defect

    Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.

    Product
    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2321-2017·2017-06-14

    Hill Country Fare Bread Recalled Due to Presence of Rubber

    HEB Retail Support Center is recalling Hill Country Fare and Good brand breads due to the presence of rubber in the product.

    Product
    Hill Country Fare Thin Sandwich UPC 4122046090; Hill Country Fare Extra Thin Sandwich UPC 4122063420; Good Thin Bread; Good Bread Texas Toast; Clear Prison This; Clear Prison X-Thin all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2310-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2323-2017·2017-06-14

    HEB White Wheat Bread Recalled Due to Rubber Presence

    HEB is recalling White Wheat Bread and Texas Toast because rubber was found in the product. Consumers should check their bags for the specific best-by date.

    Product
    White Wheat Bread and White Wheat Texas Toast all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2220-2017·2017-06-14

    Iba Dosimetry Recalls Large Stealth Chamber Dosimeters for Measurement Deviations

    Iba Dosimetry is recalling 110 Large Stealth Chambers because they may show measurement deviations and geometric shadowing when used as reference detectors.

    Product
    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2324-2017·2017-06-14

    HEB White Rice Recalled in Texas Due to Rubber Presence

    HEB Retail Support Center is recalling HEB White rice in Texas because rubber was found in the product. Consumers should stop using the affected 24 oz bags.

    Product
    HEB White RT UPC 4122035774 and HEB ST White UPC 4122088001 all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0889-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.

    Product
    Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2320-2017·2017-06-14

    Denali Moose Tracks Cheesecake Recalled for Incorrect Peanut Allergen Labeling

    The Father's Table, LLC is recalling Denali Original Moose Tracks Cheesecake because the rear label is for a different product and lacks a peanut allergen declaration.

    Product
    Denali "Original" Moose Tracks Cheesecake, Net Wt. 18 oz (510g). Black plastic base with clear plastic dome. Back label includes nutrition labeling for Pumpkin Swirl Cheesecake. Manufactured by The Father's Table, LLC
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0896-2017·2017-06-14

    Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations

    Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.

    Product
    Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.

    Product
    Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2325-2017·2017-06-14

    HEB Texas Toast and X-Thin Recalled for Rubber Presence

    HEB is recalling Texas Toast and X-Thin products due to the presence of rubber. Consumers should check their bags for the specified UPCs and best-by dates.

    Product
    HEB Texas Toast UPC 4122062888 and HEB X-Thin UPC 4122084868 all units 24 oz per bag
    Category
    Food
    Distribution
    1 state