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.

18351–18375 of 21645

  • ModerateFDA (Devices)·Z-1691-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1359-2014·2014-06-11

    CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

    CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

    Product
    CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1674-2014·2014-06-11

    CryoLife Recalls BioGlue Surgical Adhesive Due to Albumin Component Failure

    CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.

    Product
    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2014·2014-06-11

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

    Product
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2014·2014-06-11

    Leica CD15 Antibody Recalled for Reduced Function Before Expiration

    Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.

    Product
    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1684-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have a weak seal or be open.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2014·2014-06-11

    Integra Licox Test Kit Recall for Erroneous Calibration Messages

    Integra LifeSciences is recalling Licox Test Kits that may display false calibration failure messages or out-of-range results when used with specific PtO2 monitors.

    Product
    Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1682-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2014·2014-06-11

    Leica Monoclonal Antibody Recalled for Reduced Functionality

    Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects

    Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2014·2014-06-11

    Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error

    Integra LifeSciences is recalling specific lots of SURFIX locking screws because some 22mm units were mislabeled as 30mm units.

    Product
    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1988-2014·2014-06-11

    Prep Enterprises Recalls Captain Kratom and Related Products

    Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals, and Kratom Pro products because they may contain Kratom.

    Product
    CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS CAPTAIN KRATOM PREMIUM THAI…
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1705-2014·2014-06-11

    Spacelabs Ultraview SL Command Module Recalled for Software Anomaly

    Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.

    Product
    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1973-2014·2014-06-04

    Price Chopper Roasted Garlic Hummus Recalled for Labeling Errors

    Golub Corporation is recalling Price Chopper brand Roasted Garlic Hummus due to a mix-up in nutrition panel and ingredients labeling.

    Product
    Price Chopper brand Hummus ROASTED GARLIC, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1974-2014·2014-06-04

    Borden Vitamin D Milk Recalled for Excess Vitamin D Content

    Borden Dairy Co. is recalling Vitamin D Milk because it contains more than double the labeled amount of Vitamin D.

    Product
    Vitamin D Milk GRADE A PASTEURIZED HOMOGENIZED; 4-oz paper, 300-gal totes, Gallons, 1/2 gallons, pints, quarts, paper 1/2 pints, 5-gal dispense bags. INGREDIENTS: MILK AND VITAMIN D3. Product is sold under the following brand names and UPC codes: American Fare: Gal: 0 72000…
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1654-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference

    Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2014·2014-06-04

    B. Braun Recalls Sprotte Spinal Needles Missing Introducer Needles

    B. Braun Medical is recalling 24-gauge Sprotte Spinal Needles and Trays because the accompanying introducer needles are missing.

    Product
    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1655-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1656-2014·2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1665-2014·2014-06-04

    GE Healthcare Recalls Centricity PACS Workstation Due to Image Rejection Error

    GE Healthcare is recalling 297 Centricity PACS Workstations because a software defect may cause images from previously displayed studies to be rejected unintentionally.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2014·2014-06-04

    Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference

    Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2014·2014-06-04

    Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference

    Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
    Category
    Medical Device
    Distribution
    Distributed nationwide