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.

12826–12850 of 21617

  • ModerateFDA (Devices)·Z-1931-2017·2017-05-10

    Anspach Effort AL-III Pneumatic System Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 19 AL-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2017·2017-05-10

    Anspach Effort Recalls 9.4cm Micro Revision Attach for Missing Service Interval

    The Anspach Effort, Inc. is recalling 11 units of the 9.4cm Micro Revision Attach, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    9.4CM MICRO REVISION ATTACH, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1945-2017·2017-05-10

    Anspach Effort Recalls XMAX Motor High Strength Hose for Missing Service Interval

    The Anspach Effort, Inc. is recalling 22 XMAX Motor High Strength Hoses because the supplied directions for use did not contain a recommended service interval.

    Product
    XMAX Motor, High Strength Hose Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2017·2017-05-10

    Anspach Effort B-Sagittal Assembly Pneumatic System Recall

    The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems because the supplied directions for use did not contain a recommended service interval.

    Product
    B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2017·2017-05-10

    Richard-Allan Scientific Recalls Shandon Rapid Chrome Kwik-Diff Kits

    Richard-Allan Scientific is recalling Shandon Rapid Chrome Kwik-Diff Kits because the Methylene Blue Solution #3 was mislabeled and actually contained Crystal Violet.

    Product
    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2007-2017·2017-05-10

    Anspach Effort Bearing Sleeve Recalled for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 121 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling 1,416 units of Renovation Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2017·2017-05-10

    Anspach Effort Recalls 11CM Angle Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 45 units of the 11CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    11CM ANGLE ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2017·2017-05-10

    Anspach Effort 8.2cm Pneumatic Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 80 units of the 8.2cm Black Max pneumatic attachment because the supplied directions for use did not include a recommended service interval.

    Product
    8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1944-2017·2017-05-10

    Anspach Effort Recalls XMAX Pneumatic Drill System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 554 XMAX Pneumatic Drill Systems because the supplied directions for use did not include a recommended service interval.

    Product
    XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2017·2017-05-10

    Smith & Nephew Recalls Renovation Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Renovation osteotome blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0688-2017·2017-05-10

    Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution

    The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2178-2017·2017-05-10

    Source Naturals Vitamin D-3 Recalled for Lower Concentrations

    Threshold Enterprises Ltd is recalling specific lots of Source Naturals Vitamin D-3 dietary supplements because testing found lower concentrations than labeled.

    Product
    Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1954-2017·2017-05-10

    Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 22 SC2100 foot controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Foot Control without Switches, SC2100 Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide