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.

9101–9125 of 21595

  • ModerateFDA (Food)·F-1327-2019·2019-05-15

    Wegmans Cilantro Lime Green Sauce Recalled for Foreign Material

    Wegmans is recalling Cilantro Lime Green Sauce in 8 oz and 0.5 gallon containers due to potential foreign material contamination.

    Product
    Wegmans Food You Feel Good About Cilantro Lime Green Sauce. A finishing sauce for meats, seafood & Veggies in 8 oz. plastic containers or .5 gallon bulk plastic containers.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1334-2019·2019-05-15

    Schreiber Foods Recalls Colby and Monterey Jack Cheese for Foreign Material

    Schreiber Foods is recalling specific brands of Colby and Monterey Jack cheese due to the presence of hard plastic foreign material.

    Product
    Shredded and blocks of Colby & Monterey Jack cheese - Labeled and Packaged: 1) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 8 oz; packaged in plastic pouches, 12 per case; 2) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 16 oz; pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1288-2019·2019-05-15

    Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2019·2019-05-15

    Medica Wash1 Solution Recalled for Ineffective Probe Cleaning

    Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.

    Product
    Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2019·2019-05-15

    Cardinal Health Recalls ChemoPlus Spill Kits Due to Latex Mismatch

    Cardinal Health is recalling ChemoPlus chemotherapy spill kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.

    Product
    ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2019·2019-05-08

    Siemens CT Scanner Recall for Potential Scan Abortion in Dual Energy Mode

    Siemens Medical Solutions is recalling 53 SOMATOM Definition Edge CT scanners due to a software issue that may cause scans to abort in Dual Spiral Dual Energy mode.

    Product
    SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1235-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Potential Measurement Inaccuracy

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2019·2019-05-08

    AmEx Pharmacy Recalls Bevacizumab Syringes Due to Defective Delivery System

    AmEx Pharmacy is recalling 249 syringes of Bevacizumab intravitreal injection because the delivery system is difficult to express.

    Product
    BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2019·2019-05-08

    American Health Packaging Recalls Glipizide Extended-Release Tablets for Dissolution Failure

    American Health Packaging is recalling 2,203 cartons of Glipizide Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications at time zero.

    Product
    GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2019·2019-05-08

    Siemens Atellica IM aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.

    Product
    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2019·2019-05-08

    Bard Medical Recalls ArcticGel Pads Due to Adhesion Defects

    Bard Medical Division is recalling specific lots of ArcticGel Pads because the hydrogel may not adhere properly to the pad.

    Product
    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2019·2019-05-08

    Randox G-6-PDH Deficient Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 14 kits of G-6-PDH Deficient Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1223-2019·2019-05-08

    Matrix Surgical Recalls 46 OmniPore Implants Due to Mislabeling

    Matrix Surgical Holdings is voluntarily recalling 46 OmniPore Surgical Implants due to product mislabeling. The recall covers units distributed in the US and several international countries.

    Product
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2019·2019-05-08

    Randox G-6-PDH Normal Control Recalled for Incorrect Target Values

    Randox Laboratories is recalling 10 kits of G-6-PDH Normal Control because the target values and ranges in specific lots are incorrect.

    Product
    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1237-2019·2019-05-08

    PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy

    PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1320-2019·2019-05-08

    Harmless Harvest Recalls Mango Yogurt Drinks Due to Packaging Defect

    Harmless Harvest is voluntarily recalling specific lots of its Mango Dairy-Free Yogurt Drink because a packaging defect may cause premature spoilage.

    Product
    Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink; Probiotic Mango. 8 fl. oz. plastic bottle; UPC 859078-002993
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1234-2019·2019-05-08

    Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.

    Product
    SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1264-2019·2019-05-08

    GE Healthcare Recalls 16 NM/CT 870 CZT Systems for Screw Issue

    GE Healthcare is recalling 16 NM/CT 870 CZT systems because detector screws may not be secured correctly, potentially compromising mounting redundancy.

    Product
    NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine syste
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1242-2019·2019-05-08

    BioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results

    BioFire Diagnostics is recalling the FilmArray Gastrointestinal (GI) Panel due to elevated rates of false positive results for Campylobacter and Cryptosporidium.

    Product
    FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with Fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2019·2019-05-08

    PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results

    PerkinElmer is recalling AutoDELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.

    Product
    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1322-2019·2019-05-08

    Rice Valley Noodles Recalled for Undeclared Yellow 5 and 6 Dyes

    Rice Valley Foods is recalling Ready Cooked and Instant Noodles because FDA inspection found undeclared Yellow 5 and 6 dyes.

    Product
    Rice Valley Ready Cooked Noodles and Instant Noodles, Net Wt, 14 oz. plastic bag - Perishable, Keep Refrigerate UPC 9 92320 40305 3, UPC: 9 9230 40301 5 Made in USA Rice Valley Foods Company, San Francisco, CA 94124
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1258-2019·2019-05-08

    GE Healthcare Recalls Discovery NM/CT 670 CZT Systems for Mounting Defect

    GE Healthcare is recalling three Discovery NM/CT 670 CZT systems because detector screws may not be secured correctly, potentially compromising detector mounting redundancy.

    Product
    Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medici
    Category
    Medical Device
    Distribution
    0 states