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.

17726–17750 of 21645

  • ModerateFDA (Food)·F-0016-2015·2014-10-15

    Mothers' Milk Bank of Montana Recalls Frozen Pasteurized Human Milk

    Mothers' Milk Bank of Montana is recalling 12 bottles of frozen pasteurized human milk because a donor received live vaccines after delivery.

    Product
    Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0024-2015·2014-10-15

    Siemens Recalls Dimension Vista Mass CKMB Isoenzyme Calibrator Due to Drift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Mass CKMB Isoenzyme Calibrators because routine stability monitoring showed drift exceeding acceptance criteria.

    Product
    Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0015-2015·2014-10-15

    NatureBox Cranberry Macaroon Granola Recalled for Incorrect Back Label

    NatureBox is recalling 1,262 pouches of Cranberry Macaroon Granola because the back label incorrectly displays ingredients and nutrition for Cherry Berry Granola.

    Product
    naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for cherry berry granola labeled in part as: Ingredients: Whole grain oats, brown sugar, dried cranberries (cranberries, sugar, sunflower oil)…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0041-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

    Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0008-2015·2014-10-15

    Hostess Frosted Bagged Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling Frosted Bagged Donettes due to potential mold growth caused by higher-than-average moisture content.

    Product
    Hostess Frosted Bagged Donettes, 11.25 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Compromise

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may affect sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0017-2015·2014-10-15

    Mothers' Milk Bank of Montana Recalls Unpasteurized Human Milk

    Mothers' Milk Bank of Montana is recalling frozen unpasteurized human milk because a donor received live vaccines after delivery.

    Product
    Frozen Unpasteurized Human Milk in glass bottle. No labeling provided
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0010-2015·2014-10-15

    Hostess Powdered Donettes Recalled for Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of Powdered Single-Serve Donettes due to higher-than-average moisture content that may allow mold growth.

    Product
    Hostess Powdered Single-Serve Donettes, 3 oz., 6 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0012-2015·2014-10-15

    Hostess Recalls Frozen Donettes Due to Potential Mold Growth

    Hostess Brands LLC is recalling specific lots of frozen Donettes because laboratory analysis found higher-than-average moisture content, creating a potential for mold growth.

    Product
    Hostess Powdered Bagged Donettes- FROZEN ONLY, 10.5 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2015·2014-10-15

    VistaPharm Recalls Metoclopramide Oral Solution Due to Leaking Containers

    VistaPharm is recalling 322,650 cups of Metoclopramide Oral Solution because the containers leak when inverted.

    Product
    METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0008-2015·2014-10-15

    Astellas Recalls Tarceva Tablets Due to Failed Dissolution Specifications

    Astellas Pharma US Inc is recalling 9,236 bottles of Tarceva (erlotinib) 150 mg tablets because they failed routine stability testing for dissolution.

    Product
    Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2015·2014-10-15

    Navilyst Medical Recalls PICC Kits Due to Potential Sterility Issues

    Navilyst Medical is recalling specific PICC Convenience Kits because they contain BD syringes with open seals that may compromise sterility.

    Product
    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2525-2014·2014-10-08

    Goya and Jibarito Pink Beans Recalled for Can Seam Defect

    Tradewind Foods is recalling Goya and Jibarito Pink Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Pink Beans sold under two brand names Goya and Jibarito (see labels description below) Goya Pink Beans Habichuelas Rosadas 15.5 oz. (439g) El Jibarito Habichuelas Rosadas 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2720-2014·2014-10-08

    Siemens Dimension Vista CHEM 1 CAL Recall for Magnesium Calibration Error

    Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.

    Product
    Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2528-2014·2014-10-08

    Goya Pinto Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Pinto Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1616-2014·2014-10-08

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

    Actavis is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol tablets due to complaints of split or broken tablets.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2728-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

    Instrumed International is recalling 71 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2015·2014-10-08

    Recall of ENVOY 500 AST Reagent Kits Due to Quality Control Failures

    ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.

    Product
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2724-2014·2014-10-08

    Instrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions

    Instrumed International is recalling 3,093 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2727-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 895 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2527-2014·2014-10-08

    Goya Red Kidney Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2730-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Warnings

    Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2734-2014·2014-10-08

    Baro-Therapies Rejuvenator Chamber Recalled for Lack of FDA Approval

    Baro-Therapies, Inc. is recalling 10 Rejuvenator Chambers because they were distributed without an approved 510(k).

    Product
    The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
    Category
    Medical Device
    Distribution
    Distributed nationwide