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.

19976–20000 of 21633

  • ModerateFDA (Devices)·Z-2196-2013·2013-09-25

    Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues

    Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.

    Product
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2242-2013·2013-09-25

    3M Recalls Scotchcast Cast Padding Due to Water Repellency Issues

    3M is voluntarily recalling specific lots of Scotchcast Wet or Dry Cast Padding because the material does not consistently repel water, which may prolong cast drying times.

    Product
    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2189-2013·2013-09-18

    Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error

    Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.

    Product
    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2013·2013-09-18

    Medical Indicators Recalls Tempa DOT Single-Use Clinical Thermometers

    Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.

    Product
    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2013·2013-09-18

    HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1877-2013·2013-09-18

    Stonyfield Organic Soy Yogurt Recalled for Coliform Levels

    Stonyfield Farm is recalling 1,680 cups of Organic O Soy Yogurt Strawberry due to coliform levels exceeding product specifications.

    Product
    Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1037-2013·2013-09-18

    Qualitest Recalls Effervescent Potassium Chloride Tablets Due to Labeling Error

    Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.

    Product
    EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL…
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1036-2013·2013-09-18

    Qualitest Recalls K Effervescent Tablets Due to Labeling Mix-up

    Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.

    Product
    K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook…
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2174-2013·2013-09-18

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps

    Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.

    Product
    STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2139-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 30 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1874-2013·2013-09-11

    Justin's Recalls Maple Almond Butter Due to Metallic Fragments

    Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.

    Product
    Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2133-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak

    DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during…
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2137-2013·2013-09-11

    Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters

    Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.

    Product
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1)…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2146-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1868-2013·2013-09-11

    Potter's Crackers Recalled for Tree Nut Cross-Contamination

    Potters Fine Foods is recalling 109 packages of Classic White Crackers due to cross-contamination with a walnut-containing dough.

    Product
    Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree…
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1873-2013·2013-09-11

    Hawaii Fresh Sweet and Thai Basil Recalled for Pesticide Residues

    Crown Pacific International is recalling sweet and Thai basil due to a Hawaii cease and desist order for positive pesticide samples.

    Product
    Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2156-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel 2.5 mL because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1859-2013·2013-09-11

    Contoocook Creamery Recalls Salted Butter Due to Elevated Bacterial Counts

    Contoocook Creamery is recalling salted butter in 8oz tubs and 5-gallon pails due to elevated coliform and standard plate counts.

    Product
    Butter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2138-2013·2013-09-11

    Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices

    Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.

    Product
    Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2046-2013·2013-09-04

    Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling

    Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.

    Product
    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2013·2013-09-04

    Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2013·2013-09-04

    Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions

    Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.

    Product
    SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2013·2013-09-04

    Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis

    Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.

    Product
    TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
    Category
    Medical Device
    Distribution
    1 state