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.

11176–11200 of 21617

  • ModerateFDA (Devices)·Z-0769-2018·2018-03-07

    Steris Recalls Vis-U-All Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0855-2018·2018-03-07

    Schmidt Baking Recalls Wheat Bread Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various wheat bread products due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    ALDIS S/T WHEAT BREAD ( Under the following Trade Names - ALDIS ST WHEAT, HAUSWALD, CHERRY VALLEY, COMPARE, FINEFARE, , HP, KEYFOODS, METFOODS, PIONEER,SUPERA, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GEORGES, REDER )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0820-2018·2018-03-07

    Accord Media Recalls Truth Renew Device for Unapproved LED Light

    Accord Media, LLC is recalling 30 units of the Truth Renew device because it uses an unapproved green LED light to treat hyperpigmentation.

    Product
    Truth Renew
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0793-2018·2018-03-07

    Avid Medical Recalls TruCustom Lower Extremity Kits Due to Foreign Material

    Avid Medical is recalling 120 TruCustom Lower Extremity convenience kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0872-2018·2018-03-07

    Meijer Recalls Greek Yogurt Due to Potential Glass Particles

    Meijer Distribution is voluntarily recalling select Greek and Low-fat yogurt products due to a precautionary measure regarding the potential risk of small glass particles.

    Product
    Meijer Greek Yogurt 0% Plain 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0826-2018·2018-03-07

    Tosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits

    Tosoh Bioscience is recalling ST AIA-PACK Progesterone III Assay kits because cross-reactivity with DHEA-S supplements can cause falsely elevated test results.

    Product
    ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-0821-2018·2018-03-07

    Accord Media Recalls Ultra Renew Plus LED Light Device

    Accord Media, LLC is recalling 1,040 units of the Ultra Renew Plus medical device because it uses an unapproved green LED light to treat hyperpigmentation.

    Product
    Ultra Renew Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0868-2018·2018-03-07

    Bell Plantation Recalls Powdered Peanut Butter Due to E. coli Levels

    Bell Plantation Inc. is recalling 6,011 jars of Ready-to-Eat Powdered Peanut Butter because analytical results for non-pathogenic E. coli exceeded the firm's internal specifications.

    Product
    Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0846-2018·2018-03-07

    Schmidt Baking Recalls White Sandwich Dinners Due to Foreign Material Risk

    Schmidt Baking Co. is recalling white sandwich dinners under several brands due to a potential foreign material in an ingredient supplied by a vendor.

    Product
    WHITE S/T DINNERS ( Under the following Trade Names - HARVEST PRIDE, HARVEST PRIDE 8 COUNT, BLUE RIBBON, GIANT, PLAIN BAG AND ROCKLAND )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0704-2018·2018-03-07

    Philips ProGrade R1 Digital X-Ray Detector Recall for Image Transfer Failures

    Philips is recalling 157 ProGrade R1 digital x-ray detectors because weak WiFi connections can cause image transfer failures, requiring patients to be re-exposed to radiation.

    Product
    digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0759-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0863-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Bread Due to Foreign Material Risk

    Schmidt Baking Co. is recalling specific white wheat bread products because a vendor ingredient may contain foreign material.

    Product
    WHITE WHEAT R/T ( Under the following Trade Names - O/T 2PK, O/T, WEIS, ULTRA GRAIN )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0848-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling White Wheat Hams under OT, WEIS, and ULTRA GRAIN brands due to potential foreign material from a recalled ingredient.

    Product
    WHITE WHEAT HAMS( Under the following Trade Names - OT, WEIS, ULTRA GRAIN )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0789-2018·2018-03-07

    Avid Medical Recalls TruCustom Kits with Foreign Material in Needles

    Avid Medical is recalling TruCustom GENERAL PACK kits because some contain needles with loose polypropylene foreign material above release specifications.

    Product
    AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0778-2018·2018-03-07

    Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion

    Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0779-2018·2018-03-07

    Alcon Recalls 25+ TOTALPLUS Vitrectomy Pak Due to Probe Mismatch

    Alcon is recalling specific lots of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0504-2018·2018-02-28

    Levofloxacin Hemihydrate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

    Arrow International Inc is recalling 5,926 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0535-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0492-2018·2018-02-28

    Fluconazole USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

    Product
    Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2018·2018-02-28

    FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Testosterone Enanthate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

    Product
    Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.

    Product
    Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

    Product
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2018·2018-02-28

    Voluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues

    Vygon is voluntarily recalling specific lots of Nutrisafe 2 syringes because packaging adhesive gaps may compromise sterility.

    Product
    Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0478-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide