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.

11451–11475 of 21617

  • ModerateFDA (Drugs)·D-0246-2018·2018-02-07

    JCB Laboratories Recalls Subpotent Cefuroxime Ophthalmic Injection Syringes

    JCB Laboratories is recalling 6,510 syringes of Cefuroxime Ophthalmic Solution for Injection because the product is subpotent prior to its expiration date.

    Product
    Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0252-2018·2018-02-07

    Medline Recalls Povidone-Iodine Prep Pads Due to Low Iodine Content

    Medline Industries is recalling Aplicare Povidone-Iodine Prep Pads because the iodine content is below the labeled claim.

    Product
    Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0471-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0305-2018·2018-02-07

    Medline Incision Drainage Kit Recalled for Subpotent Iodine Content

    Medline is recalling Incision Drainage Kits because the iodine content is below the labeled claim. The product was distributed nationwide and internationally.

    Product
    Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2018·2018-02-07

    Edwards HemoSphere System Recalled for Pre-Procedural Software Defects

    Edwards Lifesciences is recalling 198 HemoSphere System devices due to pre-procedural software defects. The devices are distributed in 11 US states.

    Product
    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0699-2018·2018-02-07

    Mom's Delicious Kitchen Recalls Kvas Due to Compromised Package Integrity

    Mom's Delicious Kitchen LLC is recalling gallon jugs of Kvas because holes were punched in the lids, compromising package integrity.

    Product
    Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingredients: Water, Cane Sugar, Instant Coffee, Yeast, Apple Cider***Home made to your taste with Low Calories! Keep Refrigerated to Prevent from pe
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0296-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Catheter Insertion Trays

    Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0264-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.

    Product
    Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0490-2018·2018-02-07

    Maquet Recalls Expired Hemofiltration Standard Packs for Cardiopulmonary Bypass

    Maquet is recalling 55 Hemofiltration Standard Packs distributed after their September 2015 expiration date. The units were used in extracorporeal circulation during cardiopulmonary bypass procedures.

    Product
    Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0269-2018·2018-02-07

    Medline Sheath Removal Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.

    Product
    Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0442-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0421-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0251-2018·2018-02-07

    Premier Pharmacy Labs Recalls Mitomycin Vials Due to Labeling Error

    Premier Pharmacy Labs is recalling 193 vials of Mitomycin 40 mg/mL due to a label error on the declared strength.

    Product
    Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0284-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim of 0.85%.

    Product
    Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0497-2018·2018-02-07

    Smiths Medical Recalls Graseby 3300 Pumps Due to Key Mismatch

    Smiths Medical is recalling 77 Graseby 3300 syringe pumps and accessories because the supplied lock and key may not match the standard key.

    Product
    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0481-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0491-2018·2018-02-07

    Tosoh AIA-900 Analyzer Recalled for Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0249-2018·2018-02-07

    Taro Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure

    Taro Pharmaceuticals is recalling 27,792 tubes of Clobetasol Propionate Cream 0.05% because the product failed content uniformity specifications.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2018·2018-02-07

    Medline Newborn Kit Recalled for Subpotent Povidone-Iodine Prep Pads

    Medline Industries is recalling 288 cases of Newborn Kits because the Povidone-Iodine prep pads contain subpotent iodine, falling below the 0.85% label claim.

    Product
    Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0641-2018·2018-01-31

    Blommer Chocolate Recalls ERNIES Candy Due to Potential Foreign Material

    Blommer Chocolate Company is recalling 20,000 lbs of ERNIES chocolate candy because missing pieces from light shields may have contaminated the product.

    Product
    Blommer Chocolate Company ERNIES (chocolate candy centers with candy shell) Net Wt. 25 lbs. Ingredients: Sugar, cocoa, hydrogenated palm kernel oil, whey, artificial color (FD&C Blue No. 1, Blue No 1 Lake, Blue #2 Lake, Yellow #5, Yellow No. 5 Lake, Yellow No. 6, Yellow No.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0392-2018·2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results

    Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Medical Device
    Distribution
    0 states