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.

10351–10375 of 21617

  • ModerateFDA (Devices)·Z-2319-2018·2018-07-04

    St Jude Medical Recalls Ellipse ICDs for Security Firmware Update

    St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.

    Product
    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2331-2018·2018-07-04

    BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues

    BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.

    Product
    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2286-2018·2018-07-04

    Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation

    Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.

    Product
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·058-2018·2018-07-02

    Nueske's Recalls Pork Products Due to Undeclared Ingredients

    Nueske's Meat Products is recalling approximately 12,946 pounds of braised pork products because they may contain undeclared brown rice flour and glycerin.

    Product
    Nueske's Meat Products, Inc. — Recall Notification Report 058-2018 (Pork Products)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2244-2018·2018-06-27

    Stryker Farabeuf Clamp Recalled for Incorrect Laser Etching on Lever Arm

    Stryker GmbH is recalling Farabeuf Clamps for 3.5mm Screws PRO because laser etching indicating compression or distraction mode is on the wrong side of the lever arm.

    Product
    Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0888-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling 130,081 bottles of Atorvastatin Calcium 40 mg tablets nationwide due to failed impurity and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2259-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2261-2018·2018-06-27

    Paragon 28 Recalls P28 JAWS Nitinol Staple Kits Due to Missing Drill Guide

    Paragon 28, Inc. is recalling P28 JAWS Nitinol Staple System kits because the drill guide is missing from the package.

    Product
    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2270-2018·2018-06-27

    Olympus JF-160F Duodenoscopes Recalled for New Reprocessing Procedures

    Olympus Corporation of the Americas is recalling 68 JF-160F duodenoscopes nationwide to implement validated new reprocessing procedures.

    Product
    Olympus JF-160F duodenoscopes (Model NumberJF-160F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they failed impurities and degradation specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0878-2018·2018-06-27

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object

    Dr. Reddy's Laboratories is recalling 6,397 bottles of Atorvastatin Calcium 80 mg tablets because a foreign object was found embedded in a tablet.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2268-2018·2018-06-27

    Smith & Nephew Recalls Birmingham Hip Resurfacing Acetabular Cups for Labeling Defects

    Smith & Nephew is recalling six Birmingham Hip Resurfacing Acetabular Cups because they were distributed in the US with international labeling instead of FDA-approved instructions.

    Product
    Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2258-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2260-2018·2018-06-27

    BD Vacutainer Plus Plastic Citrate Blood Collection Tubes Recalled for Overfill

    Becton Dickinson is recalling BD Vacutainer Plus Plastic Citrate Blood Collection Tubes because approximately 3.4% of units exhibit overfill draw volumes.

    Product
    The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateUSDA FSIS·052-2018·2018-06-21

    Agri Star Recalls Beef Pastrami Due to Processing Deviation

    Agri Star Meat and Poultry is recalling approximately 3,592 pounds of ready-to-eat beef pastrami due to possible underprocessing and inadequate curing.

    Product
    Agri Star Meat and Poultry, LLC — Agri Star Meat And Poultry LLC Recalls Beef Pastrami Products due to Possible Processing Deviation
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0873-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Teething and Nausea Drops

    MBi Nutraceuticals is voluntarily recalling several homeopathic products, including teething and nausea drops, due to a lack of adequate manufacturing controls.

    Product
    Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2165-2018·2018-06-20

    BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.

    Product
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1578-2018·2018-06-20

    Yukon Jackson Coffee Toffee Recalled for Missing Pecan Allergen Labeling

    Yukon Jackson is recalling Coffee Toffee because pecans are listed in the ingredients but not in the 'Contains' statement.

    Product
    Coffee Toffee - 4 oz. packages. UPC 6 55974 89001 2. The label is read in parts: "***Ingredients: butter (milk), sugar, bittersweet chocolate 60% (cocoa liquor, emulsifier, soya lecithin, vanilla), coffee, pecans *** Contains: milk & soya ***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0871-2018·2018-06-20

    MBi Homeopathic Expectorant Cough Syrup Recalled for Lack of Processing Controls

    MBi Nutraceuticals is voluntarily recalling Expectorant Cough Syrup and other homeopathic products due to inadequate manufacturing controls.

    Product
    Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2018·2018-06-20

    Keystone Dental Recalls Mislabeled Prima Plus Dental Implants

    Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.

    Product
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and termina
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2171-2018·2018-06-20

    BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

    BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in sol
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states