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.

1576–1600 of 21710

  • ModerateFDA (Devices)·Z-0269-2026·2025-10-29

    Single 40KW 55C X-ray system recalled with water resistance reminder

    Sedecal is recalling one SM-40HF-B-D-C 40KW 55C mobile X-ray system, serial G37587, after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0276-2026·2025-10-29

    Canon ready mobile X-ray system recalled with water resistance reminder

    Sedecal is recalling one SM-40HF-B-D-C 40KW Canon Ready mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0251-2026·2025-10-29

    Twelve mobile X-ray units recalled with reminder about water resistance limits

    Sedecal is recalling 12 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.

    Product
    Model Number 40KWFXPLUS-710CW, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0261-2026·2025-10-29

    Battery analog 40KW X-ray systems recalled with water resistance reminder

    Sedecal is recalling nine SM-40HF-Batt 40KW analog mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0268-2026·2025-10-29

    Two 40KW 55G X-ray systems recalled with water resistance reminder

    Sedecal is recalling two SM-40HF-B-D-C 40KW 55G/60G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0095-2026·2025-10-29

    Zicam fruit drops recalled because label omitted elderberry as an ingredient

    Church & Dwight is recalling 21,912 bottles of Zicam Medicated Fruit Drops Elderberry Flavor because the label failed to list elderberry as an ingredient.

    Product
    ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY — ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY (ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2026·2025-10-29

    Four 40KW 50C X-ray systems recalled with water resistance reminder

    Sedecal is recalling four SM-40HF-B-D-C 40KW 50C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0264-2026·2025-10-29

    Twenty seven 40KW 50G X-ray systems recalled with cleaning reminder

    Sedecal is recalling 27 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0256-2026·2025-10-29

    Battery analog 32KW X-ray systems recalled with water resistance reminder

    Sedecal is recalling 22 SM-32HF-Batt 32KW analog mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0217-2026·2025-10-29

    uCT 530 scanners recalled because third party covers can jam table

    UIH Technologies is recalling eight uCT 530 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0225-2026·2025-10-29

    uMI Panorama PET systems recalled because third party covers can jam

    UIH Technologies is recalling four uMI Panorama 35 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.

    Product
    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0270-2026·2025-10-29

    Four 40KW 55C X-ray systems recalled with water resistance reminder

    Sedecal is recalling four SM-40HF-B-D-C 40KW 55C/60C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0255-2026·2025-10-29

    Thirty two kilowatt X-ray systems recalled with strict cleaning reminder

    Sedecal is recalling eight SM-32HF-B-D-C 32KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0031-2026·2025-10-29

    Gabapentin blister packs recalled after unknown impurity exceeded specification

    The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg in 10-capsule blister packs after routine stability testing returned an out-of-specification result for highest unknown impurity.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2026·2025-10-29

    Twelve 40KWFXPLUS X-ray systems recalled with strict cleaning reminder

    Sedecal is recalling 12 model 40KWFXPLUS.005 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number 40KWFXPLUS.005, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0228-2026·2025-10-29

    Forty six millimetre locking screws recalled over wrong length on packaging

    Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.

    Product
    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0267-2026·2025-10-29

    Forty kilowatt 55G X-ray systems recalled with water resistance reminder

    Sedecal is recalling five SM-40HF-B-D-C 40KW 55G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0034-2026·2025-10-29

    Olopatadine eye drops recalled after unspecified impurity exceeded specification limit

    USV Private Limited is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% after an unspecified impurity exceeded the specification limit.

    Product
    Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2026·2025-10-29

    Three VIR3 mobile X-ray systems recalled with water resistance reminder

    Sedecal is recalling three SM_40HF_B_D_VIR3.004 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    SM_40HF_B_D_VIR3.004, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0271-2026·2025-10-29

    One hundred eighty one 40KW 70C X-ray systems recalled with cleaning reminder

    Sedecal is recalling 181 SM-40HF-B-D-C 40KW 70C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

    Product
    Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
    Category
    Medical Device
    Distribution
    3 states