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.

19801–19825 of 21751

  • ModerateFDA (Food)·F-0220-2014·2013-11-27

    Swanson Black Cumin Seed Capsules Recalled for Mislabeling

    Swanson Health Products is recalling two lots of Black Cumin Seed capsules because they contain White Cumin Seed instead.

    Product
    Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0337-2014·2013-11-27

    GE Healthcare Recalls Centricity Perinatal and Intensive Care Software

    GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.

    Product
    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0222-2014·2013-11-27

    CTF Brand Tapioca Pearl Pandan Recalled for Missing Ingredient Labeling

    N A Trading Inc is recalling CTF Brand Tapioca Pearl Pandan because the packaging fails to list Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1.

    Product
    CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:"C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS…
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0376-2014·2013-11-27

    Ivoclar Vivadent Recalls ExciTE F DSC Dental Adhesive Due to Discoloration

    Ivoclar Vivadent is recalling ExciTE F DSC Dental Adhesive because it produces blue-green discoloration when used with cements.

    Product
    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0311-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 544 units distributed worldwide.

    Product
    VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 units distributed worldwide.

    Product
    VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0135-2014·2013-11-20

    Specialty Enzymes Recalls Cellulase and Protease Products for Chloramphenicol

    Specialty Enzymes & Biotechnologies is recalling cellulase and protease products because they may contain low levels of chloramphenicol.

    Product
    Cellulase & Protease: APEX 10-639 A DIGESEB DIGESEB PLUS DIGESEB SUPER EB 10-14171 EB 10-16192 EB 12-11331 EB 12-9205 EB 14-14201 EB 15-13662 EB 18-13081 EB 7-12831 EB 7-12901 EB 7-14211 EB 8-15731 EL 5-7212 ENZIGEST N FIZYME # 1209 N GLOBAL 8-658 HERB…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2014·2013-11-20

    Baxter Recalls SIGMA SPECTRUM Infusion Pump LCD Screens for Discharge Failure

    Baxter Healthcare is recalling 346 SIGMA SPECTRUM Infusion Pump LCD screens that failed to withstand electrostatic discharge.

    Product
    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading into the viewer under specific conditions.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0210-2014·2013-11-20

    Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues

    Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.

    Product
    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0243-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0226-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0272-2014·2013-11-20

    Biotene Moisturizing Mouth Spray Recalled for Incorrect Ingredient Labeling

    GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray because the label lists sorbitol, but the product does not contain it.

    Product
    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0127-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. Consumers should check their pantries for the specific affected lot.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0225-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0129-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects 4,512 cases distributed across eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry UPC 36632 02720.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0194-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-0173-2014·2013-11-20

    Torn Ranch Fruit Truffles Recalled for Undeclared Yellow Dyes

    Torn Ranch Inc. is recalling specific fruit truffle flavors because Yellow #5 and #6 dyes were not declared on the label.

    Product
    Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut…
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0245-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0227-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0247-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states