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.

1826–1850 of 21710

  • ModerateFDA (Food)·H-0454-2025·2025-08-20

    Imported soda biscuits recalled for undeclared whole milk powder and wheat

    Soda Biscuit (Sea Salt Fresh Milk Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.

    Product
    Soda Biscuit (Sea Salt Fresh Milk Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865031
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2321-2025·2025-08-20

    Medication dispensing cabinets recalled after reports of delayed access during override workflow

    BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.

    Product
    Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2025·2025-08-20

    SIGNA Hero XT patient table caster lock checks may have been missed

    GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Product
    GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2302-2025·2025-08-20

    Optima MR450w 1.5T MRI recalled where caster lock maintenance may be unperformed

    GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2298-2025·2025-08-20

    Ultra IABP catheter kits carry indications not reviewed by the FDA

    Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.

    Product
    Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2025·2025-08-20

    SIGNA Artist Evo MRI recalled over unverified patient table caster lock checks

    GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0443-2025·2025-08-20

    Lithium orotate 2.5 mg product recalled for failing labeled potency specification

    Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.

    Product
    Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2025·2025-08-20

    Discovery MR750 3.0T systems recalled over patient table caster lock maintenance gap

    GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0447-2025·2025-08-20

    Mecene lithium orotate capsules recalled after an out of specification ingredient

    Lithium Orotate capsules distributed by Mecene LLC are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.

    Product
    Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 mg UPC#: X002T4OPLL 10 mg UPC#: X0031AXVE9
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2314-2025·2025-08-20

    SIGNA Premier Elite MRI recalled because caster lock maintenance check may be missing

    GE HealthCare is recalling SIGNA Premier Elite (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2307-2025·2025-08-20

    Discovery MR750w patient table caster lock checks may have been missed

    GE Discovery MR750w 3.0T MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 519 units affected.

    Product
    GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0442-2025·2025-08-20

    Lithium orotate 1 mg product recalled for failing labeled potency requirement

    Lithium Orotate 1 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.

    Product
    Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2300-2025·2025-08-20

    Signa Voyager MRI recalled where patient table caster lock checks unconfirmed

    GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2319-2025·2025-08-20

    SIGNA PET/MR AIR system recalled where caster lock maintenance may be missing

    GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.

    Product
    GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0441-2025·2025-08-20

    Bulk lithium orotate ingredient recalled after testing below its labeled concentration

    Actylis brand Lithium Orotate 4% and 9%, packaged in HDPE liners in 25 kg cartons, is recalled because the material tested at 3% and 4.45% respectively.

    Product
    a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·H-0417-2025·2025-08-13

    Yoplait Harvest Peach yogurt recalled after a shipping trailer temperature excursion

    Yoplait Original Harvest Peach Yogurt, 6 oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.

    Product
    Yoplait Original Harvest Peach Yogurt, 6 OZ (170g), packaged in a plastic cup, UPC: 170470003075
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2258-2025·2025-08-13

    Major thoracoscopy basins contain an inadvertently resterilized visualization system

    Major Thoracoscopy Basin medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 128 units are affected.

    Product
    MAJOR THORACOSCOPY BASIN. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·H-0413-2025·2025-08-13

    Silk vanilla almondmilk recalled after a shipping trailer temperature excursion

    Silk Vanilla AlmondMilk, 64 fl oz, is being recalled because of temperature abuse following a temperature excursion in one shipping trailer. 1 unit is affected.

    Product
    Silk Vanilla AlmondMilk, 64 FL OZ (2 QT) 1.89 L, packaged in a paper carton, UPC: 025293000995
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2250-2025·2025-08-13

    GYN laparoscopy packs contain an inadvertently resterilized visualization system

    GYN Laparoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 346 units are affected.

    Product
    GYN LAPAROSCOPY PACK. Medical convenience kit.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2271-2025·2025-08-13

    DxI 600 with Spot B analyzer motor current resets below requirement

    DxI 600 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 177 systems are affected.

    Product
    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
    Category
    Medical Device
    Distribution
    Distributed nationwide