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.

15476–15500 of 21645

  • ModerateFDA (Devices)·Z-0469-2016·2015-12-30

    Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression

    Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.

    Product
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0476-2016·2015-12-30

    Dental Dressing Recall Due to Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressol-X and Dressit-X dental dressings because the labels do not list the percentage of drug components.

    Product
    Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2016·2015-12-30

    DePuy Mitek Recalls VAPR Tripolar Suction Electrodes Due to Button Color Error

    DePuy Mitek is recalling 127 VAPR Tripolar 90 Degree Suction Electrodes because the ablation and coagulation buttons are colored incorrectly. The wiring is correct, and the issue affects button color only.

    Product
    VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0497-2016·2015-12-30

    Ameditech DrugSmart Cup 10 Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart Cup 10 units because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0468-2016·2015-12-30

    Siemens Factor VIII Chromogenic Assay Recalled for Irregular Curves

    Siemens Healthcare Diagnostics is recalling Factor VIII Chromogenic Assay kits due to irregular curves on specific Sysmex systems, which may cause erroneously increased results.

    Product
    Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0529-2016·2015-12-30

    Ameditech ProScreen 6 Panel Dip Drug Screen Recall for Reduced Reactivity

    Ameditech is recalling ProScreen 6 Panel Dip Drug Screen kits due to reduced reactivity for two specific benzodiazepine compounds.

    Product
    ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0542-2016·2015-12-30

    Ameditech Recalls Thermo Fisher 8 Drug Cassettes Due to Reduced Reactivity

    Ameditech is recalling 100 Thermo Fisher 8 Drug Cassettes because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2016·2015-12-30

    Philips Ingenuity CT System Recall for Perfusion Software Access Issue

    Philips is recalling 31 Ingenuity CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2016·2015-12-30

    Siemens Artis Fluoroscopic X-ray Systems Recalled for Display Soldering Defect

    Siemens is recalling 17 Artis fluoroscopic X-ray systems due to improper soldering in display modules that could cause video signal loss.

    Product
    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0477-2016·2015-12-30

    Dental Dressing Recall for Missing Drug Component Percentages

    Rainbow Specialty & Health Products is recalling Dressit-X dental dressings because the labeling does not list the percentage of drug components.

    Product
    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2016·2015-12-30

    Philips CT System Recall for Missing Perfusion Scan Feature

    Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2016·2015-12-30

    Shimadzu Mobile X-ray Systems Recalled for Image Transfer Issues

    Shimadzu Medical Systems is recalling 297 Mobile X-ray systems because images may not transfer properly to the image server.

    Product
    Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0488-2016·2015-12-30

    Ameditech 12-Panel Dip Drug Screen Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 12-Panel Dip Drug Screen kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0490-2016·2015-12-30

    Ameditech Benzodiazepine Test Kits Recalled for Reduced Reactivity

    Ameditech Inc is recalling 31,472 Benzodiazepine Strip Dip Card kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    BZO Strip Dip Card (300ng/ml)*, Item No. 100170
    Category
    Medical Device
    Distribution
    Distributed nationwide