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.

9476–9500 of 21595

  • ModerateFDA (Food)·F-0803-2019·2019-02-13

    Wisconsin Cheese Group Recalls Mimoso Queijo Minas Fresco Farmer's Cheese

    Wisconsin Cheese Group is recalling Mimoso Queijo Minas Fresco Farmer's Cheese because it was transported at elevated temperatures.

    Product
    Mimoso Queijo Minas Fresco Farmer's Cheese. Net Wt. 12 oz (340g) UPC 19753-00052 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0799-2019·2019-02-13

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover

    Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

    Product
    ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2019·2019-02-13

    Bard Medical Recalls SureStep Foley Tray System Due to Leakage Risk

    Bard Medical Division is recalling SureStep Foley Tray Systems because urine may leak around the vent on the vented sample port.

    Product
    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A30491
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0773-2019·2019-02-13

    NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error

    Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY tran
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0804-2019·2019-02-13

    Richard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects

    Richard Wolf GmbH is recalling 873 Bronchoscope Tubes, Model Texas, because non-functional bonding points may loosen. The devices are used for respiratory tract investigation and therapy.

    Product
    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0810-2019·2019-02-13

    Mimoso Queijo Minas Frescal Cheese Recalled for Temperature Violation

    Wisconsin Cheese Group is recalling Mimoso Queijo Minas Frescal cheese because it was transported at elevated temperatures. The product was distributed in New Jersey and New York.

    Product
    Mimoso Queijo Minas Frescal. Net Wt. 28 oz (793g) UPC 19753-0050 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0800-2019·2019-02-13

    Bard SureStep Foley Tray System Recalled for Potential Sample Port Leaks

    Bard Medical Division is recalling 450 units of SureStep Foley Tray Systems because the sample ports may leak urine.

    Product
    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0815-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling 1,260 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0807-2019·2019-02-13

    Wisconsin Cheese Group Recalls Sabor Brasil Queijo Minas Frescal Cheese

    Wisconsin Cheese Group is recalling Sabor Brasil Queijo Minas Frescal Cheese because it was transported at elevated temperatures.

    Product
    Sabor Brasil Queijo Minas Frescal Cheese Net Wt. 17.6 oz (498g) UPC 19753-00049 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0426-2019·2019-02-13

    US Pharmaceuticals Recalls Hydrocortisone Cream Due to Microbial Contamination

    US Pharmaceuticals is recalling Hydrocortisone Cream Intensive Healing due to out-of-specification microbial counts in purified water.

    Product
    HYDROCORTISONE CREAM INTENSIVE HEALING — HYDROCORTISONE CREAM INTENSIVE HEALING (HYDROCORTISONE CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0804-2019·2019-02-13

    Wisconsin Cheese Group Recalls Sabor Brasil Minas Cheese Due to Temperature Issues

    Wisconsin Cheese Group is recalling Sabor Brasil Minas Farmer's Cheese because it was transported at elevated temperatures. The product was distributed in New Jersey and New York.

    Product
    Sabor Brasil Queijo Minas / Minas Farmer's Cheese. Net Wt. 3 lbs / 1.36kg UPC 19753-00075 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0843-2019·2019-02-13

    AdvoCare SleepWorks Liquid Supplement Recalled for Unapproved Ingredient

    AdvoCare International is recalling SleepWorks Liquid Vitamin & Mineral Herbal Supplement because it contains beta phenyl gamma aminobutyric acid HCl.

    Product
    SleepWorks Liquid Vitamin & Mineral Herbal Supplement 12 single serving bottles - 2 Fl Oz (60 mL) Net 24 Fl Oz (720 mL), product code W3721
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0796-2019·2019-02-13

    Medtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions

    Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.

    Product
    MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0425-2019·2019-02-13

    US Pharmaceuticals Recalls Soothe & Cool Protect Moisture Guard Skin Protectant

    US Pharmaceuticals is recalling Soothe & Cool Protect Moisture Guard Skin Protectant due to out-of-specification microbial counts in purified water.

    Product
    Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0420-2019·2019-02-06

    Progesterone 100 mg SR Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 1,306 capsules of Progesterone 100 mg SR due to a lack of processing controls.

    Product
    Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0419-2019·2019-02-06

    Promethazine Gel Recalled by Duren Health Mart Pharmacy for Processing Control Issues

    Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL due to a lack of processing controls. The affected product was distributed in Tennessee.

    Product
    Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0414-2019·2019-02-06

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2019·2019-02-06

    Siemens Recalls Atellica Sample Handler Prime Due to Software Issues

    Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.

    Product
    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2019·2019-02-06

    Abbott Recalls Alinity i Processing Modules Due to Gear Pump Assembly Issue

    Abbott is recalling Alinity i Processing Modules because a gear pump assembly issue causes foaming and dried residue in the wash buffer reservoir.

    Product
    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0421-2019·2019-02-06

    Domperidone 10 mg Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0416-2019·2019-02-06

    Duren Health Mart Pharmacy Recalls Omeprazole Suspension Due to Processing Controls

    Duren Health Mart Pharmacy is recalling Omeprazole 4 mg/mL Suspension because of a lack of processing controls. The recall is limited to Tennessee.

    Product
    Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0415-2019·2019-02-06

    Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter

    H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.

    Product
    GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0418-2019·2019-02-06

    Testosterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Testosterone 0.1% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0417-2019·2019-02-06

    Progesterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Progesterone 10% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0775-2019·2019-02-06

    Wilson-Cook Medical Recalls Mislabeled Captura Serrated Forceps

    Wilson-Cook Medical is recalling 6 units of Captura Serrated Forceps due to mislabeling that swapped spike and no-spike models.

    Product
    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
    Category
    Medical Device
    Distribution
    0 states