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.

9626–9650 of 21595

  • ModerateFDA (Food)·F-0686-2019·2018-12-12

    Black River Industries Recalls Italian Spice Blend Due to Plastic Contamination

    Black River Industries is recalling Italian Spice Blend Salt Free because it may contain plastic foreign material. The product was distributed to Wisconsin correctional facilities.

    Product
    Italian Spice Blend Salt Free in 2 Lb. plastic bottles and 20 Lb. bulk boxes. Ingredients; Basil, Rosemary, Oregano, Marjoram & Spices. Not labeled for Resale.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0554-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Due to Leaking Granular Material

    Pfizer is recalling Thermacare Muscle Pain Therapy HeatWraps because the wraps may come apart and leak granular material.

    Product
    Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0687-2019·2018-12-12

    Frutarom Recalls Sugar-Free Syrup Containing Sugar

    Frutarom USA Inc. is recalling 1,018 bottles of Sebastiano's French Vanilla syrup because the product contains sugar despite being labeled 'Naturally Sugar Free.'

    Product
    Sebastiano s Naturally Flavored Gourmet Syrups French Vanilla Naturally Sugar Free, Sweetened with Stevia; 25.4 fl. oz. (750 ml)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0688-2019·2018-12-12

    Frozen Peach Dices Recalled for Foreign Plastic Material

    Titan Farms is recalling 192 cases of Tickled PEACHES Freestone Dices due to the presence of foreign plastic material.

    Product
    Tickled PEACHES Freestone Dices; Net wt 4.4 oz. (125g) sealed plastic cups; KEEP FROZEN; Palmetto Processing Solutions 5 RW Dubose Road Ridge Spring, SC 29129 UPC 0110817134020432
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0682-2019·2018-12-12

    NOW Foods Recalls Mislabeled Vitamin B-50 Complex Vegetable Capsules

    NOW Foods is voluntarily recalling 61 bottles of Vitamin B-50 Complex with C 100 Veg Caps because they are mislabeled as Vitamin B-50 mg 100 Veg Caps.

    Product
    NOW Vitamin B-50 Complex with C 100 Veg Caps
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0528-2019·2018-12-12

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition

    Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.

    Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1208-2019·2018-12-05

    Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

    Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

    Product
    Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0499-2019·2018-12-05

    Siemens Dimension Vista Lactate Dehydrogenase Reagent Cartridge Recall

    Siemens is recalling Dimension Vista Lactate Dehydrogenase reagent cartridges because they may produce falsely elevated results if used after Lactic Acid assays.

    Product
    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2019·2018-12-05

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Distribution Error

    Stryker Sustainability Solutions is recalling 4,848 reprocessed Xcel Bladeless Trocars (H12LP) because they were distributed to facilities after a previous recall was executed.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocess
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2019·2018-12-05

    GE Healthcare Recalls Dash 3000 Patient Monitoring Systems

    GE Healthcare is recalling Dash 3000 patient monitors because they may restart simultaneously during prolonged network overloads.

    Product
    Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2019·2018-12-05

    Allergan Recalls INFed Iron Dextran Injection for Stability Failure

    Allergan is recalling INFed (Iron Dextran Injection) vials because they failed stability specifications for iron content. The product was distributed throughout the United States.

    Product
    INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0510-2019·2018-12-05

    Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

    Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because the Instructions for Use booklets were not included on the outer pouch.

    Product
    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0509-2019·2018-12-05

    Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure

    Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0517-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to the presence of a foreign substance.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2019·2018-12-05

    PerkinElmer QSight 210 MD Mass Spectrometer Software Data Overwrite Recall

    PerkinElmer is recalling 18 QSight 210 MD mass spectrometers because a software defect may overwrite original data from the last acquired sample when automatic flush is enabled.

    Product
    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0495-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0493-2019·2018-11-28

    BD Urine Collection Cups May Elevate Red Blood Cell Counts

    Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0492-2019·2018-11-28

    BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.

    Product
    BD Vacutainer Specimen Collection Cups, Cat. No. 364975
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0477-2019·2018-11-28

    Binding Site Human IgM Kit Recalled for Reduced Accuracy

    The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative an
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0489-2019·2018-11-28

    Merck Minicon Clinical Sample Concentrators Recalled for Performance Issues

    Merck Millipore is recalling Minicon Clinical Sample Concentrators because they may take up to 24 hours to concentrate samples, delaying diagnostic tests.

    Product
    Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0485-2019·2018-11-28

    Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing

    Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient results.

    Product
    Tosoh AIA-900 immunoassay Analyzer
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0667-2019·2018-11-28

    Diamond Crystal Barbecue Sauce Recalled for Missing Ingredient Labels

    Diamond Crystal Brands is recalling House Blend Barbecue Sauce because the labels are missing required ingredient information, including soybean oil.

    Product
    HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BRANDS, INC. SAVANNAH, GA 31405
    Category
    Food
    Distribution
    11 states