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.

11701–11725 of 21617

  • ModerateFDA (Devices)·Z-0179-2018·2017-12-06

    Arrow VPS Access Kit Recalled for Potential Size Mismatch

    Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2018·2017-12-06

    Implant Direct Legacy Dental Implants Recalled for Packaging Defect

    Implant Direct Sybron Manufacturing is recalling 75 units of Legacy 3 Dental Implants because a packaging defect may compromise sterilization.

    Product
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2018·2017-12-06

    Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs

    Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.

    Product
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0409-2018·2017-12-06

    Reese Pharmaceutical Recalls Orange Flavor Immune Support Effervescent Tablets

    Reese Pharmaceutical is recalling Orange Flavor Immune Support Effervescent Tablets because the label does not list sodium in the ingredient statement.

    Product
    Orange Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Best Choice UPC 0 70038 60863 9 & UPC 0 70038 60863 9; Discount Drug Mart UPC 0 93351 00909 9; Freds Mart UPC 0 84579 12451 0; Good Neighbor Ph
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-0090-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Balm for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Balm due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0378-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Pizza Kits Due to Ink Pen Contamination

    Champion Foods is recalling Little Caesar's DEEP!DEEP! Dish Kits and other bread products due to potential ink pen contamination from a supplier.

    Product
    Little Caesar's DEEP!DEEP! Dish Kits, Paper cartons, Contains: 4 pizza crusts ( 9.5 inches x 6 inches), 4 packages of pizza sauce, 4 package of cheese, 1 re-sealable package of pepperoni, 4 trays
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0380-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Crazy Bread Kits for Physical Contaminants

    Champion Foods is recalling Little Caesar's Crazy Bread Kits due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Crazy Bread Kits, Paper cartons, Contains: 3 bread crusts (18 pcs.), 3 packages of Garlic Buttery Sauce, 3 packets of Parmesan cheese, 3 packets of Crazy Sauce
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0088-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Spray for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Spray due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally H
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0086-2018·2017-11-29

    Ridge Properties Recalls Bed Sore Cream Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine due to inadequate manufacturing control processes.

    Product
    Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0084-2018·2017-11-29

    FDA Recalls Unapproved Faiza Beauty Cream Distributed in New York

    The FDA is recalling No. 1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0165-2018·2017-11-29

    Abbott Clinical Chemistry Systems Recalled for Tubing Leak Risk

    Abbott is recalling 34 ARCHITECT c4000, c8000, and c16000 clinical chemistry systems because a manufacturing issue with the peristaltic head tubing may cause leaks.

    Product
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0161-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Software

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.

    Product
    ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2018·2017-11-29

    Lorazepam Tablets Recalled Due to Incorrect Strength Labeling

    Leading Pharma, LLC is recalling Lorazepam tablets labeled as 0.5 mg but containing 1 mg. The recall addresses a labeling error affecting 2,952 bottles nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0169-2018·2017-11-29

    Resource Optimization Recalls Regard Custom Surgical Packs Due to Label Error

    Resource Optimization & Innovation LLC is recalling 51 units of Regard Custom Surgical Packs because they contain a 3ml ChloraPrep With Tint unit with an incorrect label.

    Product
    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0375-2018·2017-11-29

    Champion Foods Recalls Cheesy Breadsticks Due to Potential Ink Pen Contamination

    Champion Foods is voluntarily recalling frozen Cheesy Breadsticks and other bread products due to potential physical contaminants from an ink pen.

    Product
    Cheesy Breadsticks, 9.98 oz. 24 or 25 units per case, or 22.75 oz. 12 units per case, frozen
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0083-2018·2017-11-29

    United Therapeutics Recalls Tyvaso Inhalation Devices Due to Manufacturing Deviations

    United Therapeutics is voluntarily recalling 12 Tyvaso Inhalation System Starter Kits due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0379-2018·2017-11-29

    Champion Foods Recalls Little Caesar's Italian Cheese Bread Kits

    Champion Foods is recalling Little Caesar's Italian Cheese Bread Kits due to potential physical contaminants from an ink pen.

    Product
    Little Caesar's Italian Cheese Bread Kits, Paper cartons, Contains: 3 square bread crusts (10 inches), 3 packages of Garlic Butter sauce, 3 packages of cheese, 3 packages of Italian Seasoning
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0089-2018·2017-11-29

    Ridge Properties Recalls Naturally HL Hemorrhoid Gel Due to Manufacturing Issues

    Ridge Properties, LLC is recalling Naturally HL Liquid Hemorrhoid Relief Gel due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Natu
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0168-2018·2017-11-29

    Siemens Recalls Syngo.plaza PACS Software Due to Image Count Discrepancy

    Siemens Medical Solutions is releasing a software tool to fix an issue where Syngo.plaza PACS displays fewer de-archived images than archived.

    Product
    Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the ph
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0087-2018·2017-11-29

    FDA Recalls Extra Strength PreTAT Gel Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel because of inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0373-2018·2017-11-29

    Henning's Wisconsin Cheese Colby Jack Recalled Due to Pasteurization Record Failure

    Henning Cheese, Inc. is recalling 4,253 lbs of Colby Jack cheese because a temperature recorder failed to log pasteurization data for the first vat.

    Product
    Henning's Wisconsin Cheese Colby Jack, Colby & Monterey Jack Blended Together. Packaged in 1 lb., 2 lb, and mammoth wheels (A mammoth wheel can be classified as anything 75 lbs. and larger).
    Category
    Food
    Distribution
    2 states