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.

13176–13200 of 21617

  • ModerateFDA (Devices)·Z-1115-2017·2017-02-08

    Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors

    Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.

    Product
    Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2017·2017-02-08

    Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies

    Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.

    Product
    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1116-2017·2017-02-08

    Siemens Syngo.plaza PACS Software Recall for Issue Resolution

    Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.

    Product
    Syngo.plaza, picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1117-2017·2017-02-08

    Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.

    Product
    VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2017·2017-02-08

    Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error

    Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.

    Product
    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1427-2017·2017-02-08

    Roland Manzanilla Olives Stuffed With Anchovies Recalled for Microorganisms

    Roland Foods is recalling Manzanilla Olives Stuffed With Anchovies because FDA sampling found non-pathogenic Gram Positive Rods.

    Product
    Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 OZ. (85g), UPC Code: 41224714021 and Case UPC Code: 10041224714028, Item # 71402, PRODUCT OF SPAIN
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1356-2017·2017-02-01

    Berner Lite Creamy Alfredo Pasta Sauce Recalled for Spoilage Bacteria

    Berner Food & Beverage is recalling 1,224 cases of Lite Creamy Alfredo pasta sauce contaminated with spoilage bacteria.

    Product
    Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, metal lid; NET WT. 15 OZ, CONT. NET 425g; UPC 41220898732
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1359-2017·2017-02-01

    Berner Food & Beverage Recalls Roasted Garlic Alfredo Pasta Sauce

    Berner Food & Beverage is recalling 70 cases of Roasted Garlic Alfredo Pasta Sauce contaminated with spoilage bacteria.

    Product
    Roasted Garlic Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 36800334779
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1069-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield falsely low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1080-2017·2017-02-01

    Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues

    Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

    Product
    Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1348-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, fruit punch flavor (UPC 764779-420734), fruit punch (UPC 764779-430740). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1349-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, green apple (UPC 764779-430740). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0444-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling 588 bottles of Temozolomide Capsules, 250 mg, due to customer complaints of broken capsules and loose powder in the bottles.

    Product
    Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2017·2017-02-01

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    Sun Pharmaceutical Industries is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets because they failed dissolution specifications and a 18-month stability time point.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2017·2017-02-01

    Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging

    Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2017·2017-02-01

    Binding Site Human IgG Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG Subclass Kits because they may produce falsely low results for patients with extremely high IgG4 levels.

    Product
    Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1082-2017·2017-02-01

    Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues

    Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.

    Product
    Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2017·2017-02-01

    Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.

    Product
    Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1093-2017·2017-02-01

    Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation

    Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.

    Product
    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0441-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling specific lots of Temozolomide Capsules, 100 mg, because customer complaints reported broken or crushed capsules resulting in loose powder in the bottles.

    Product
    Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2017·2017-02-01

    Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues

    Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.

    Product
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
    Category
    Medical Device
    Distribution
    12 states