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.

18301–18325 of 21645

  • ModerateFDA (Food)·F-2014-2014·2014-06-18

    La Terra Fina Spinach and Kale Dip Recalled for Labeling Error

    La Terra Fina Inc. is recalling specific lots of Spinach & Kale Dip and Spread because one lot's ingredient statement incorrectly lists ingredients for spinach dip.

    Product
    La Terra Fina All Natural Spinach & Kale Dip and Spread; Made with Greek Yogurt; Net Wt. 10 oz. (.625 lb) 284 g UPC 6 40410 51350 1; La Terra Fina, Union City, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1776-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 188 sterile neuro drill accessories because some units have missing or partial notches, which may affect their use with Elite attachments.

    Product
    Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1736-2014·2014-06-18

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.

    Product
    VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1768-2014·2014-06-18

    Stryker 5.0mm Barrel Bur Recall Due to Missing Notches

    Stryker is recalling 15 units of 5.0mm Barrel Bur Sterile because some units may have missing or partial notches.

    Product
    Stryker 5.0mm Barrel Bur Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1759-2014·2014-06-18

    Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 84 sterile 5.5mm Round Fluted Bur Aggressive devices because some units have missing or partial notches.

    Product
    Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1381-2014·2014-06-18

    Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended Release Tablets because they failed dissolution testing at 18 months.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2014·2014-06-18

    Cenorin HLD Systems Model 610 Washer Recalled for Cleaning Fluid Defect

    Cenorin LLC is voluntarily recalling 25 HLD Systems Model 610 Washer/High Level Disinfector units because they may not inject the proper amount of cleaning fluid, potentially failing to reduce debris.

    Product
    HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1641-2014·2014-06-18

    Smiths Medical Recalls Mislabelled Portex Low Dead Space Connectors

    Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport because 3.0mm devices were packaged and labeled as 3.5mm.

    Product
    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1751-2014·2014-06-18

    Stryker 2.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 252 sterile 2.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2014·2014-06-18

    Stryker Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 609 sterile 3.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2014·2014-06-18

    Stryker Lindemann Drill Short Recalled for Missing Notches

    Stryker is recalling 12 Lindemann Drill Short units because some cutting accessories may have missing or partial notches.

    Product
    Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1777-2014·2014-06-18

    Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories

    Stryker is recalling 497 sterile neuro drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite attachments.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2014·2014-06-18

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software issue that may cause biased results when using Multiple Window codes.

    Product
    VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1781-2014·2014-06-18

    Synthes Mandible Plate Cutter Recalled for Potential Corrosion

    Synthes, Inc. is recalling 14 units of the Matrix Mandible Short Cut Plate Cutter due to potential discoloration and corroded material on the tool's face.

    Product
    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1767-2014·2014-06-18

    Stryker 6.0mm Egg Bur Recall Due to Missing Notches

    Stryker is recalling 65 units of 6.0mm Egg Bur sterile surgical instruments because some units have missing or partial notches.

    Product
    Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1770-2014·2014-06-18

    Stryker 6.0mm Acorn Bur Recalled for Missing Notches

    Stryker is recalling 59 sterile 6.0mm Acorn Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1752-2014·2014-06-18

    Stryker 4.0mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 281 units of 4.0mm Round Fluted Burs because some may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2010-2014·2014-06-18

    Mandelin Recalls Marzipan for Undeclared Yellow Dyes 5 and 6

    Mandelin Inc is recalling marzipan products containing undeclared Yellow #5 and #6 dyes. The affected items were distributed in California, Kentucky, and Colorado.

    Product
    Marzipan - Pink, Orange and Green; Packed in 1 lb, (16 oz.) plastic containers and and 10.5 lb. 4.76 kg) pails. Ingredient: Sugar, almonds, potassium sorbate, oil of bitter almonds. Mandelin: California Almonds and Almond Pastes, Wasco California 93280
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1750-2014·2014-06-18

    Stryker Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 72 sterile 1.0mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2014·2014-06-18

    Stryker 6.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 256 units of 6.0mm Round Fluted Bur due to missing or partial notches that may affect compatibility with Elite Attachments.

    Product
    Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2014·2014-06-18

    McKesson Horizon Medical Imaging Software Recalled for Archive Access Issues

    McKesson Medical Imaging is recalling Horizon Medical Imaging software after a complaint that an unreported study could not be opened from the archive.

    Product
    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from…
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-1775-2014·2014-06-18

    Stryker Neuro Drill Soft Touch Recalled for Missing Notches

    Stryker is recalling 802 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems configured with TCAutomation Software v3.5 due to potential buffer timeout issues.

    Product
    enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1778-2014·2014-06-18

    Stryker Precision Neuro Drill Recall Due to Missing Notches

    Stryker is recalling 6,481 Precision Neuro Drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide