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.

16276–16300 of 21645

  • ModerateFDA (Devices)·Z-1960-2015·2015-07-08

    Spine Wave Access Kit Recalled for Mislabeled Probe Dimensions

    Spine Wave, Inc. is recalling 121 Spine Wave Access Kits because the outer carton mislabels the monopolar probe dimensions. The probe is listed as 200 x 1.5mm instead of the correct 280 x 1.5mm.

    Product
    Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2015·2015-07-08

    Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

    Product
    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2015·2015-07-08

    Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2015·2015-07-08

    Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.

    Product
    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1206-2015·2015-07-08

    Takeda Recalls Contrave Tablets Due to Broken or Split Defects

    Takeda Pharmaceuticals is recalling 3,619 bottles of Contrave extended-release tablets due to potential tablet defects, including broken tablets and equatorial splitting.

    Product
    CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2015·2015-07-08

    Roche Lactate Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.

    Product
    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2015·2015-07-08

    Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1925-2015·2015-07-08

    Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.

    Product
    HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D1151-2015·2015-07-08

    Qualitest Recalls Disulfiram Tablets Due to Dissolution Failure

    Qualitest Pharmaceuticals is recalling 2,016 bottles of Disulfiram tablets because one lot failed routine stability testing for dissolution specifications.

    Product
    Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2015·2015-07-08

    Palindrome HSI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2015·2015-07-08

    LifeHealth IRMA TRUPoint 443914 Recalled for Barometric Pressure Drift

    LifeHealth is recalling seven IRMA TRUPoint 443914 devices because their barometric pressure measurements drift over time, potentially affecting critical care analyte results.

    Product
    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1940-2015·2015-07-08

    Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

    Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

    Product
    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2015·2015-07-08

    Roche Uric Acid Plus Test Recalled for Drug Interference

    Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

    Product
    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2015·2015-07-08

    Boston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error

    Boston Scientific is recalling one lot of Extractor Pro RX Retrieval Balloon Catheters because the device contains a syringe size larger than what is identified on the label.

    Product
    Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2772-2015·2015-07-01

    Refreshe Lime Flavored Electrolyte Water Recalled for Coliform Contamination

    The Sweetwater Co. is recalling Refreshe Lime Flavored Electrolyte Water due to high total coliform testing results.

    Product
    Lime Flavored Electrolyte bottled Water, sold under brand Refreshe. Each bottle is 1 Liter (33.8 Fl. oz.). This brand has the UPC 0 21130-24208 5.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1833-2015·2015-07-01

    ArthroCare Medical Recalls PROcise XP Wand Due to Component Failure

    ArthroCare Medical is recalling 2,355 PROcise XP Wand units because a potential component failure may cause the device to become inoperable during use.

    Product
    PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2015·2015-07-01

    Terumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves

    Terumo is recalling 163 custom cardiovascular procedure kits and over-pressure safety valves because the valves are not cleared for use on the arterial side of the bypass circuit.

    Product
    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-2734-2015·2015-07-01

    Golden Chocolate Recalls Raisin Pound Cake for Undeclared Food Colorings

    Golden Chocolate International is recalling Raisin Pound Cake because it contains undeclared FD&C Yellow #5, Yellow #6, and Red #40 food colorings.

    Product
    Golden Chocolate RAISIN POUND CAKE, Net Wt. To be Weighed at Time of Sale. Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1844-2015·2015-07-01

    Volcano PV .035 Catheter Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 PV .035 Catheters because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2739-2015·2015-07-01

    Eating Right Black Bean Soup Recalled for Potential Mispackaging

    San Francisco Spice Company is recalling Eating Right Black Bean Soup because some containers may contain Spicy Thai Noodle soup instead.

    Product
    Eating Right Black Bean Soup; 1.3 oz paper container. Dried soup to which consumer adds hot water. USPC: 79893-80026; Ingredients: Ingredients: Black Beans*, Vegetables* (Tomato, Potato, Corn, Peppers, Garlic), Natural Flavor (Yeast Extract, Maltodextrin, Sunflower Oil, Silicon…
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1832-2015·2015-07-01

    ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure

    ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.

    Product
    EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2015·2015-07-01

    Volcano Prestige Plus J-Tip Wire Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 Prestige Plus 185cm J-Tip pressure wires because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2766-2015·2015-07-01

    Coca-Cola Recalls Diet Dr. Pepper Labeled as Regular Dr. Pepper

    Coca-Cola is recalling 4,772 cases of Diet Dr. Pepper that were incorrectly labeled as containing regular Dr. Pepper. The product was distributed in six southeastern states.

    Product
    Diet Dr. Pepper, 8 x 12 fl. oz. PET bottle, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 85024.
    Category
    Food
    Distribution
    6 states