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.

14576–14600 of 21645

  • ModerateFDA (Devices)·Z-1722-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 689 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 33 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1398-2016·2016-06-01

    Sinco Recalls Archer Farms Frozen Pizza Due to Plastic Contamination

    Sinco is recalling Archer Farms Greek-Inspired Spinach & Feta Cheese Artisan Pizza because a consumer found a small piece of gray plastic in the product.

    Product
    archer farms Greek-Inspired Spinach & Feta Cheese ARTISAN PIZZA, NET WT 14.9 OZ (425g). UPC Code: 0-85239-30714-4. Pizza is frozen.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2016·2016-06-01

    Biomet PerFuse Decompression Instrument Recall Due to Missing Parts

    Biomet, Inc. is recalling 22 PerFuse Decompression Instruments because missing Trocar and Plunger Assemblies could delay surgery by more than 30 minutes.

    Product
    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1712-2016·2016-06-01

    RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug

    RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.

    Product
    RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-0858-2016·2016-06-01

    Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Defective Valve

    Lymol Medical is recalling Sclerosol Intrapleural Aerosol because a defective stem valve may cause the canister to leak propellant, resulting in no drug or an inadequate dose being delivered.

    Product
    Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2016·2016-06-01

    Accriva APTT Cuvettes Recalled Due to Mis-positioned Reagent

    Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high results.

    Product
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1386-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Watermelon, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1710-2016·2016-06-01

    Synthes 3.2 mm Radiolucent Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.

    Product
    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1387-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling all lot codes of Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet FDA dietary ingredient definitions.

    Product
    Undisputed , all lot codes, Flavors: Lemon Lime, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1367-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling all lot codes of Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Blue Raspberry, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1704-2016·2016-06-01

    Leica Calretinin Antibody Recalled for Reduced Staining Performance

    Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1708-2016·2016-06-01

    Stryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters

    Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.

    Product
    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1790-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 338 boxes of Delicot sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2016·2016-06-01

    Volcano Cardiology Imaging Systems Recalled for Network Compatibility Reboot Issue

    Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.

    Product
    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2016·2016-06-01

    Synthes 3.2 mm Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.

    Product
    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1390-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement Due to Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Sour Apple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1402-2016·2016-06-01

    Zochem Recalls Zinc Oxide Powder Contaminated with Iron

    Zochem Inc. is recalling zinc oxide powder lots contaminated with iron. The product is used in manufacturing dietary supplements and drugs.

    Product
    Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1349-2016·2016-05-25

    Bunge Canola Frying Oil Blend Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 1,923 cases of Yum Canola Frying Oil Blend due to the presence of foreign material inside the jugs.

    Product
    Yum Canola Frying Oil Blend, Net Wt., 35 lbs. (15.88 kg), Packaged Exclusively for use by Yum! Brands Global Restaurants, Yum Brands, Louisville, KY 40232
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1345-2016·2016-05-25

    Bunge Canola Oil Recalled for Foreign Material in Jugs

    Bunge Oil North America Inc. is recalling Old World Clear Canola Liquid Frying Oil due to the presence of a foreign material inside the jugs.

    Product
    Old World Clear Canola Liquid Frying Oil (Aceite de Canola Para Freir Liquido y Transparente), Net Wt.35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70021 9
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1357-2016·2016-05-25

    Bunge Corn Oil Recalled for Foreign Material in Jugs

    Bunge Oil North America Inc. is recalling 180 cases of Bunge Corn Oil due to the presence of foreign material inside the jugs.

    Product
    Bunge Corn Oil (Aceite de maiz), Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 69118 0
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1667-2016·2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Medical Device
    Distribution
    2 states