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.

18326–18350 of 21645

  • ModerateFDA (Devices)·Z-1761-2014·2014-06-18

    Stryker Elite Bur Recall Due to Missing Notches

    Stryker is recalling 2.0mm Tapered Round Elite Burs because some units have missing or partial notches. The devices are used for cutting bone during surgery.

    Product
    Stryker 2.0mm Tapered Round Elite 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1738-2014·2014-06-18

    Ortho-Clinical enGen Laboratory Automation Systems Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems with specific TCAutomation software versions due to a potential delay in reporting patient sample test results.

    Product
    enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2014·2014-06-18

    Stryker 0.5mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 27 sterile 0.5mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 0.5mm 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-1779-2014·2014-06-18

    Stryker 5.0mm Barrel Bur Recall for Missing Notches

    Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may affect their use with Elite Attachments.

    Product
    Stryker 5.0mm Barrel 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-1737-2014·2014-06-18

    Beckman Coulter Recalls Ultrasonic Transducer Kits Due to Incorrect Screws

    Beckman Coulter is recalling 82 Ultrasonic Transducer Kits because they may have been assembled with incorrect mounting screws.

    Product
    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1780-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 916 sterile neuro drill cutting accessories due to missing or partial notches that may affect device performance.

    Product
    Stryker 3.0mm x 3.8mm Neuro Drill Less 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2014·2014-06-18

    Teleflex Recalls RUSCH Easy Cath Coude Kits Due to Incorrect Catheter Type

    Teleflex Medical is recalling 1,000 RUSCH Easy Cath Coude Kits because they were packaged with straight catheters instead of the required curved ones.

    Product
    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1757-2014·2014-06-18

    Stryker 4.5mm Round Fluted Bur Recall for Missing Notches

    Stryker is recalling 62 units of 4.5mm Round Fluted Bur Aggressive Sterile devices due to missing or partial notches.

    Product
    Stryker 4.5mm 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 (Devices)·Z-1763-2014·2014-06-18

    Stryker Recalls Four Zyphr Elite Round Fluted Bur Units

    Stryker is recalling four sterile Zyphr Elite Round Fluted Bur units due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 5.0mm Zyphr Elite 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1773-2014·2014-06-18

    Stryker Wire Pass Drill Recalled for Missing Notches

    Stryker is recalling 246 sterile 1.5mm Wire Pass Drills because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 1.5mm Wire Pass 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-1766-2014·2014-06-18

    Stryker 5.0mm Egg Bur Recall Due to Missing Notches

    Stryker is recalling 144 units of 5.0mm Egg Bur sterile devices because some cutting accessories may have missing or partial notches.

    Product
    Stryker 5.0mm 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 (Food)·F-2007-2014·2014-06-11

    American Spoon Sour Cherry Preserves Recalled for Potential Mold Contamination

    American Spoon Foods is recalling 2,887 jars of Sour Cherry Preserves because they may contain mold. Consumers should check their jars and stop using them if they match the description.

    Product
    American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and…
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1688-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS due to potential pouch seal failures that could compromise sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 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-1360-2014·2014-06-11

    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 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2014·2014-06-11

    Small Bone Innovations Recalls Non-Sterile RingFIX Olive Wires

    Small Bone Innovations is recalling non-sterile RingFIX Olive Wires because they were packaged with the wrong internal component.

    Product
    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2009-2014·2014-06-11

    Rockman Skinless Peanuts Recalled for Mold and Mislabeling

    Rockman Company USA Inc. is recalling skinless peanuts due to mold contamination and mislabeling. The affected product was distributed in several US states.

    Product
    Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Packaged in plastic pouch. 12oz/60bags/carton. Product labeling reads in part: "ROCKMAN***SKINLESS PEANUT 12 0Z (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF…
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1696-2014·2014-06-11

    Bard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 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-1687-2014·2014-06-11

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

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

    Product
    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 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-1681-2014·2014-06-11

    Synthes XRL Medium Trial Central Body Recalled for Incorrect Dimension Etching

    Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device because they were incorrectly etched with the wrong height dimensions.

    Product
    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1985-2014·2014-06-11

    Gavina Dark Whole Bean Coffee Recalled for Mislabeling as Decaffeinated

    F. Gavina & Sons Inc. is recalling 29 units of Gavina Northwest Blend Dark Whole Bean Coffee because it was mislabeled as decaffeinated.

    Product
    Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb, Product label reads in part "***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***"
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1695-2014·2014-06-11

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

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 8" Circle because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 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-1689-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 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-1693-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterility Compromise

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

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide