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.

20726–20750 of 21633

  • ModerateFDA (Food)·F-1062-2013·2013-03-20

    LYFE Kitchen Sweet Corn Chowder Recalled for Incorrect Packaging Sleeve

    LYFE Kitchen is recalling Sweet Corn Chowder because some containers were packaged in sleeves labeled for Orange Carrot Ginger Soup. The product itself is correctly labeled.

    Product
    LYFE Kitchen, Sweet Corn Chowder with Cashew Cream, Yukon Gold Potatoes and Bell Peppers; 28 oz. 680 gr, Keep Refrigerated. UPC 855764003527 Del Monaco Specialty Products, Morgan Hill, CA
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1065-2013·2013-03-20

    Yoruk Prens Drink Mix Recalled for Prohibited Colorants

    Ethnic International Holding Inc. is recalling Yoruk Prens drink mix because it contains colorants not allowed in the USA.

    Product
    POMEGRANATE DRINK MIX. Yoruk Prens Nar Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of pomegranate on label.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0944-2013·2013-03-20

    Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws

    Smith & Nephew is recalling 90 units of Trigen internal hex reconstruction screws because 75 mm and 80 mm lengths were packaged in incorrect boxes and labels.

    Product
    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0925-2013·2013-03-20

    Biomet Recalls Straight Acetabular Inserter Handles Due to Latch Interference

    Biomet, Inc. is recalling 58 non-sterile Straight Acetabular Inserter Handles because they may lock onto the cup during surgery, potentially causing delays.

    Product
    REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0948-2013·2013-03-20

    Siemens CT Software Recall for Sporadic 3D Reconstruction Hang-Ups

    Siemens Medical Solutions is recalling 896 Somatom CT systems due to sporadic software malfunctions that cause 3D reconstructions to hang during preview.

    Product
    Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0936-2013·2013-03-20

    Bacterin Elutia Silicone Surgical Wound Drain Recalled for Cracks

    Bacterin International is recalling specific lots of Elutia silicone surgical wound drains because a portion of the drain was found to be cracked.

    Product
    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-192-2013·2013-03-20

    K C Pharmaceuticals Recalls Eye Drops With Incorrect Back Labeling

    K C Pharmaceuticals is recalling 31,704 bottles of Eye Drops advanced relief because the back labels fail to list three active ingredients.

    Product
    Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1064-2013·2013-03-20

    Yoruk Prens Drink Mix Recalled for Prohibited Colorants

    Ethnic International Holding Inc. is recalling Yoruk Prens drink mix because it contains colorants not allowed in the USA.

    Product
    ORANGE DRINK MIX. Yoruk Prens Portalcal Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of orange on label.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1139-2013·2013-03-20

    Koda Farms Recalls Sweet Rice Flour Due to Foreign Material Report

    Koda Farms is recalling specific lots of Mochiko Blue Star Sweet Rice Flour after a customer reported finding a hard yellow material in dough made with the product.

    Product
    Mochiko Blue Star Sweet Rice Flour, Net Wt 50 lb. or packaged in 1 lb bags. Koda Farms Milling, Inc. South Dos Palos, CA. 93665
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1193-2013·2013-03-20

    Rose Valley Salted Print Butter Recalled for Antibiotic Testing Failure

    Farmers Cooperative Creamery is recalling Rose Valley Salted Print Butter because the milk used was not confirmed negative for antibiotics before processing.

    Product
    Salted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: "***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0943-2013·2013-03-20

    Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws

    Smith & Nephew is recalling 69 Trigen internal hex reconstruction screws because 75 mm and 80 mm units were packaged in incorrect boxes and labels.

    Product
    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0924-2013·2013-03-20

    Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments

    Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic abutments that were mislabeled with incorrect dimensions.

    Product
    Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1200-2013·2013-03-20

    Tausi Brand Salted Black Beans Recalled for Potential Botulism Risk

    G.L. Food Wholesale Inc. is recalling Tausi Brand Salted Black Beans due to potential pathogen growth and toxin formation from Clostridium botulinum.

    Product
    Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8…
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0923-2013·2013-03-20

    Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments

    Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic abutments because they were mislabeled as 4.0 mm 1 mm cuff units when they are actually 5.0 mm 3 mm cuff units.

    Product
    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0929-2013·2013-03-20

    Abbott Recalls Mislabeled AMO Sensar Intraocular Lenses

    Abbott Medical Optics is recalling 155 AMO Sensar Intraocular Lenses because two production orders contained mislabeled units. The lenses are distributed worldwide.

    Product
    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-193-2013·2013-03-20

    Teva Recalls Terazosin Hydrochloride Capsules Due to Foreign Capsule Presence

    Teva Pharmaceuticals USA is recalling specific lots of Terazosin Hydrochloride Capsules because a foreign capsule was found in one bottle.

    Product
    Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1063-2013·2013-03-20

    Yoruk Prens Apple Drink Mix Recalled for Unapproved Colorants

    Ethnic International Holding Inc. is recalling Yoruk Prens drink mixes because they contain colorants not allowed in the USA.

    Product
    APPLE DRINK MIX. Yoruk Prens Elma Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of green apple on label.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1066-2013·2013-03-20

    Yoruk Prens Drink Mix Recalled for Unauthorized Colorants

    Ethnic International Holding Inc. is recalling Yoruk Prens drink mix because it contains colorants not permitted in the USA.

    Product
    CINNAMON DRINK MIX. Yoruk Prens Tarcin Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of cinnamon sticks on label.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0927-2013·2013-03-20

    Innominata Lyme Disease Microplate EIA Kit Recalled for Low-Reactivity Issues

    Innominata dba GenBio is recalling 195 units of the Anti-Borrelia (Lyme) Microplate EIA Kit due to multiple incidents of low-reacting assay plates.

    Product
    ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0902-2013·2013-03-13

    Salyer Prn Biomedical Recalls Century Console Base Units

    Salyer Prn Biomedical is recalling 9 Century Console Base units because the addition of a UPS Battery Backup did not comply with FDA premarket notification regulations.

    Product
    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0913-2013·2013-03-13

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-190-2013·2013-03-13

    Actavis Recalls Amphetamine Extended-Release Capsules for Dissolution Failure

    Actavis Elizabeth LLC is recalling 9,264 bottles of amphetamine extended-release capsules because the product failed to meet dissolution specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0914-2013·2013-03-13

    Churchill Medical Recalls Lifeguard Infusion Sets Due to Labeling Error

    Churchill Medical Systems is recalling 2,340 Lifeguard Infusion Sets because the labels incorrectly identify the needle gauge and item number.

    Product
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0905-2013·2013-03-13

    Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin

    Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.

    Product
    Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide