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.

11151–11175 of 21617

  • ModerateFDA (Devices)·Z-0818-2018·2018-03-07

    Zimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors

    Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.

    Product
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0853-2018·2018-03-07

    Schmidt Baking Recalls Premium Hams Due to Potential Foreign Material

    Schmidt Baking Co. is recalling specific lots of Premium Hams because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    PREMIUM HAMS( Under the following Trade Names - 16CT RIBBON, BLUE RIBBON SUNBEAM, ALDIS)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0745-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Tubing Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Tubing 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 Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs 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 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2018·2018-03-07

    Avid Medical Recalls TruCustom Electro Physiology Kits Due to Foreign Material

    Avid Medical is recalling 15 TruCustom Electro Physiology PK convenience kits because they may contain loose polypropylene foreign material in the needles.

    Product
    AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0735-2018·2018-03-07

    Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers

    Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.

    Product
    CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0780-2018·2018-03-07

    Avid Medical Recalls TruCustom DAVINCI PACK Convenience Kits

    Avid Medical is recalling 50 TruCustom DAVINCI PACK convenience kits because they may contain needles with loose polypropylene foreign material.

    Product
    AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0718-2018·2018-03-07

    Keystone Dental Recalls Max Implant System Bone Taps Due to Mislabeling

    Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.

    Product
    Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lowe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0854-2018·2018-03-07

    Schmidt Baking Recalls Bread Products Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various bread products sold under multiple trade names due to a potential foreign material issue identified by a vendor.

    Product
    P/L HAMS( Under the following Trade Names - CHERRY VALLEY, COMPARE, FINEFARE, GIANT, GOURMET, HP, HOLSUM, KEYFOODS, KRASDALE, METFOODS, PIONEER, REDNER, SHOPPERS, SUPERA, SUPERBREAD, TOP TOMATO, TRADEFAIR, WEIS, 7 ELEVEN, HAUWALD, GREAT VALUE, GENERIC, GOURMET 16CT, REDER 16CT,
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0870-2018·2018-03-07

    Meijer Greek Yogurt Recalled for Potential Glass Particles

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

    Product
    Meijer Greek Yogurt 0% Black Cherry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0873-2018·2018-03-07

    Meijer Recalls Greek Yogurt Due to Potential Glass Particles

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

    Product
    Meijer Greek Yogurt 0% Vanilla 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0711-2018·2018-03-07

    Siemens Axiom Artis Fluoroscopic Foot Switch Recalled for Potential Failure

    Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.

    Product
    Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0720-2018·2018-03-07

    Siemens Recalls ADVIA Centaur T3 Kits Due to Barcode Scanning Issue

    Siemens is recalling ADVIA Centaur T3 kits because a barcode scanning issue on the ADVIA Centaur XPT system may affect specific lots.

    Product
    ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatmen
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0842-2018·2018-03-07

    Schmidt Baking Recalls Bread Products Due to Potential Foreign Material

    Schmidt Baking Co. is recalling various white bread products sold under multiple trade names due to a potential foreign material issue in an ingredient.

    Product
    BNS WHITE ( Under the following Trade Names - Giant, Harvest Pride -Shoprite, Sunbeam, Blueribbon, Shoppers, Weis )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0857-2018·2018-03-07

    Schmidt Baking Recalls Butter White Bread Due to Foreign Material Risk

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

    Product
    BUTTER WHITE ( Under the following Trade Names - O/T, GIANT )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0845-2018·2018-03-07

    Schmidt Baking Recalls Potato Bread Due to Potential Foreign Material

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

    Product
    P/L POTATO ( Under the following Trade Names - WHOLE FOOODS, PLAIN BAG, GIANT, HP, SHOPPERS, SHOPRITE, WEIS )
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0550-2018·2018-03-07

    Leadiant Recalls Subpotent Cystaran Cysteamine Ophthalmic Solution

    Leadiant Biosciences is recalling 1,705 bottles of Cystaran ophthalmic solution because the active ingredient was below the required strength.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0725-2018·2018-03-07

    Terumo Destination Guiding Sheath Recalled for Specification Deviation

    Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.

    Product
    Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, caroti
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0782-2018·2018-03-07

    Avid Medical Recalls Obstetrical Packs With Foreign Material in Needles

    Avid Medical is recalling obstetrical convenience kits because some contain needles with loose polypropylene foreign material above release specifications.

    Product
    AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0757-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature 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 6"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 (Devices)·Z-0831-2018·2018-03-07

    Cook Percutaneous Gastrojejunostomy Set Recalled for Backwards Wire Guides

    Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2018·2018-03-07

    Teleflex Recalls Rusch Greenlite MAC 1 Tracheal Intubation Devices

    Teleflex Medical is recalling Rusch Greenlite MAC 1 devices because some pouches may contain the incorrect product size, specifically MAC 2 instead of MAC 1.

    Product
    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
    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 (Food)·F-0844-2018·2018-03-07

    Schmidt Baking Recalls White Wheat Sandwich Dinners Due to Foreign Material

    Schmidt Baking Co. is recalling White Wheat S/T Dinners because a vendor ingredient is under recall, posing a potential foreign material hazard.

    Product
    WHITE WHEAT S/T DINNERS ( Under the following Trade Names - ULTRA GRAIN, O/T )
    Category
    Food
    Distribution
    8 states