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.

13726–13750 of 21617

  • ModerateFDA (Devices)·Z-0092-2017·2016-10-26

    Ortho VITROS URIC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0128-2017·2016-10-26

    BD Biosciences Recalls Contaminated CD79b PE Antibody Reagent

    Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.

    Product
    CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0106-2017·2016-10-26

    Triceutical Inc. Recalls Eagle Lecithin Soft Gels for Manufacturing Violations

    Triceutical Inc. is recalling Eagle Lecithin soft gels because the company failed to follow good manufacturing practices. The recall covers 1,008 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Eagle Lecithin soft gels
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0146-2017·2016-10-26

    Fresh Express American Salad Recalled for Incorrect Condiment Kits

    Fresh Express is recalling American Salad bags that may contain incorrect condiment kits. Consumers in six states should check their products.

    Product
    Fresh Express American Salad, 11 oz., Product Code G264A12B, Use-By Date OCT 05
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0190-2017·2016-10-26

    Adwe Prenatal Vitamin Recalled for Folic Acid Potency Concerns

    DNE Nutraceuticals Inc. is recalling Adwe Prenatal tablets due to a concern regarding the potency of folic acid. The recall affects 1,200 bottles distributed in New York.

    Product
    Adwe Naturals Prenatal Vitamin Manufactured for: Adwe Laboratories 1274 49 Street Brooklyn, NY 11219 UPC 040168805079
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0130-2017·2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects

    ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2017·2016-10-26

    Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference

    Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.

    Product
    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0226-2017·2016-10-26

    Hillcrest Farms Poultry Gravy Mix Recalled for Lead Contamination

    National Foods Packaging Inc is recalling Hillcrest Farms Poultry Gravy Mix because a spice ingredient was found to contain elevated levels of lead.

    Product
    Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined bags
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2017·2016-10-26

    King Henry's Recalls Gummy Frogs Due to Undeclared Colors

    King Henry's is recalling Gummy Frogs because they may contain undeclared colors FD&C Yellow #6 and Red #40.

    Product
    Gummy Frogs, 2.5oz, UPC 61054635210
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0093-2017·2016-10-26

    Tearscience Recalls LipiFlow Thermal Pulsation System Activators Due to Error Condition

    Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators because the device may automatically stop treatment during patient use.

    Product
    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic…
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0188-2017·2016-10-26

    King Henry's Gummy Frogs Recalled for Undeclared Colors

    King Henry's is recalling Gummy Frogs because they may contain undeclared food dyes. Consumers should stop eating the product.

    Product
    Gummy Frogs, 6oz, UPC 6105465200, 61054645500
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0165-2017·2016-10-26

    Entenmann's Little Bites Variety Recalled Due to Plastic Presence

    BIMBO Bakeries USA Inc. is recalling 45,600 boxes of Entenmann's Little Bites Variety due to the presence of plastic in the muffins and brownies.

    Product
    Entenmann's Little Bites Variety - 20 pouches labeled for resale 10 Chocolate Chip; 5 Blueberry; 5 Fudge Brownie; Net Wt 2 lbs.; Distributed by: Entenmann's Inc., General Offices, PO #976, Horsham, PA 19044. Best by: September 24, 2016/ 3098; UPC:7203001799
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0048-2017·2016-10-19

    Pharmedium Heparin Syringes Recalled Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 240 Heparin Sodium syringes because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0071-2017·2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 200 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0084-2017·2016-10-19

    Pharmedium Recalls Neostigmine Methylsulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 700 syringes of neostigmine methylsulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0047-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Injections Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 399 syringes of Heparin Sodium Injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0064-2017·2016-10-19

    Winco TMM3 Video-Fluoroscopy Stretcher-Chair Recalled for Non-Conforming Component

    Winco Mfg., LLC is recalling 264 TMM3 Series Video-Fluoroscopy Stretcher-Chairs because a non-conforming component caused the arms to no longer meet design specifications.

    Product
    TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient…
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0039-2017·2016-10-19

    Schafer Fisheries Recalls Fish Hot Dogs Due to HACCP Record Deficiencies

    Schafer Fisheries is recalling specific lots of fish hot dogs because of inadequate HACCP records. The products were distributed in Illinois, New York, and California.

    Product
    *** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g); Kosher Fish Products Inc. Fulton, IL FDA# 1481764; *** 2) Fish hot dogs total 15 lbs in weight packaged 120 x box with a poly liner
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0031-2017·2016-10-19

    Pharmedium Recalls ePHEDrine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,545 syringes of ePHEDrine Sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2017·2016-10-19

    Winco TMM4 Series Treatment Chair Recalled for Non-Conforming Component

    Winco Mfg. is recalling 264 TMM4 Series Multi-Purpose Treatment Chairs because a non-conforming component caused the arms to no longer meet design specifications.

    Product
    TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0083-2017·2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Soft Tissue Sleeve Guide Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Soft Tissue Sleeve Guides due to incompatibility with new revision targeting arms, which may cause surgical delays.

    Product
    Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 21,506 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0084-2017·2016-10-19

    Morrison Milling Recalls Whole Wheat Flour for Potential Nylon Fragments

    Morrison Milling is recalling 5 lb bags of The Baker's Scoop 100% Whole Wheat Flour due to the potential presence of soft nylon fragments.

    Product
    The Baker's Scoop 100% WHOLE WHEAT FLOUR NET WT. 5 LB (2.27 kg) packaged in white paper bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0053-2017·2016-10-19

    Pharmedium Recalls Ketamine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 25 syringes of ketamine HCl because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
    Category
    Drug
    Distribution
    Distributed nationwide