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.

11676–11700 of 21617

  • ModerateFDA (Devices)·Z-0209-2018·2017-12-13

    Remel Mueller-Hinton Broth Recalled for Incorrect Cation Labeling

    Remel Inc is recalling 7 units of Mueller-Hinton Broth IVD because the product label may contain incorrect cation information.

    Product
    CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0201-2018·2017-12-13

    Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch

    Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.

    Product
    Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where suffi
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0493-2018·2017-12-13

    Kroger Recalls Comforts FOR BABY Purified Water Due to Mold Complaint

    The Kroger Co. is recalling Comforts FOR BABY Purified Water with Fluoride Added after a complaint of mold was found in the product.

    Product
    Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0199-2018·2017-12-13

    DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads

    DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.

    Product
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·128-2017·2017-12-12

    Santa Fe Importers Recalls Pork Salami Due to Metal Shavings

    Santa Fe Importers, Inc. is recalling approximately 143 pounds of Marisa Premium Quality Genoa Salami Italian Brand due to possible contamination with metal shavings.

    Product
    Santa Fe Importers, Inc. — Santa Fe Importers, Inc. Recalls Ready-To-Eat Pork Products due to Possible Extraneous Material Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateNHTSA·17V790000·2017-12-08

    Forest River Recalls 2018 Salem and Wildwood Trailers for Incorrect Tire Placards

    Forest River is recalling 2018 Salem and Wildwood recreational trailers because the Federal Placard incorrectly lists the tire size, which could lead to the installation of wrong-sized tires.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0397-2018·2017-12-06

    Pure Encapsulations AI Enzymes Recalled for Undeclared Sulfites

    Pure Encapsulations is recalling AI Enzymes dietary supplements because they contain undeclared sulfites. The products were distributed in five states.

    Product
    pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0098-2018·2017-12-06

    Mayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures

    Mayne Pharma Inc is recalling 11,364 bottles of Liothyronine Sodium Tablets 25 mcg because they failed dissolution specifications. The affected lot is distributed nationwide.

    Product
    Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0431-2018·2017-12-06

    Ian's Gluten Free Panko Breadcrumbs Recalled for Potential Beetle Exposure

    Elevation Brands is recalling Ian's Gluten Free Original Panko Breadcrumbs because raw materials may have been exposed to beetles, though no insects were found in finished products.

    Product
    Ian's Gluten Free Original Panko Breadcrumbs, UPC# 7-49512-77550-0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0408-2018·2017-12-06

    Reese Pharmaceutical Recalls Berry Flavor Immune Support Tablets for Labeling Error

    Reese Pharmaceutical is recalling Berry Flavor Immune Support Dietary Supplement Effervescent Tablets because the label fails to list sodium in the ingredient statement.

    Product
    Berry Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Discount Drug Mart UPC 0 93351 01230 3; Good Neighbor Pharmacy UPC 0 87701 41330 8; Hyvee UPC 0 75450 09537 1; Kinray Preferred Plus UPC 0 23513
    Category
    Food
    Distribution
    40 states
  • 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 (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-0184-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0096-2018·2017-12-06

    Teva Recalls Clozapine Tablets Due to Potential Broken Tablets

    Teva Pharmaceuticals USA is recalling 3,870 bottles of Clozapine Tablets USP, 100 mg, due to failed specifications and potential broken tablets.

    Product
    Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0183-2018·2017-12-06

    BD Insulin Syringes Recalled for Incorrect Needle Length Labeling

    Becton Dickinson is recalling specific lots of BD Insulin Syringes because some polybags were mislabeled with the wrong needle length and gauge.

    Product
    BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0095-2018·2017-12-06

    Faiza Beauty Cream Recalled for Marketing Without FDA Approval

    New Reliance Trading, Inc. 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 NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0180-2018·2017-12-06

    Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size

    Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results

    Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2018·2017-12-06

    Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error

    Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.

    Product
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2018·2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Medical Device
    Distribution
    0 states
  • 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-0191-2018·2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
    Category
    Medical Device
    Distribution
    0 states