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.

13376–13400 of 21617

  • ModerateFDA (Devices)·Z-0385-2017·2016-12-28

    Teleflex Recalls LMA MADett Endotracheal Tubes for Inadequate Anesthesia Delivery

    Teleflex Medical is recalling LMA MADett endotracheal tubes because they may fail to atomize medication, potentially causing inadequate anesthesia.

    Product
    LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0755-2017·2016-12-28

    Real Fudge Nutty Fudge Recalled for Undeclared Blue #1 Dye

    Real Fudge is recalling Nutty Fudge due to undeclared Blue #1 dye. The product was distributed in five states.

    Product
    Nutty fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0757-2017·2016-12-28

    Real Fudge Rocky Road Recalled for Undeclared Blue #1 Dye

    Real Fudge is recalling Rocky Road Fudge because it contains undeclared Blue #1 dye. The product was distributed in five states.

    Product
    Rocky Road Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0849-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0386-2017·2016-12-28

    Teleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect

    Teleflex Medical is recalling LMA MADdy topical anesthesia sprays because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2017·2016-12-28

    Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.

    Product
    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2017·2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Short Sprayers for Anesthesia Delivery

    Teleflex Medical is recalling Flexi Nozzle Short sprayers because they may deliver a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2017·2016-12-28

    Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.

    Product
    8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0754-2017·2016-12-28

    Real Fudge Plain Fudge Recalled for Undeclared Blue Dye

    Real Fudge is recalling Plain Fudge due to undeclared Blue #1 dye. The product was distributed in five states.

    Product
    Plain Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0826-2017·2016-12-28

    Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect

    Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.

    Product
    Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0833-2017·2016-12-28

    Ben & Jerry's Brownie Batter Core Ice Cream Recalled for Plastic Pieces

    Unilever is recalling Ben & Jerry's Brownie Batter Core Ice Cream because certain pints may contain soft plastic pieces.

    Product
    Ben & Jerrys Brownie Batter Core Ice Cream One Pint (473 mL). Case UPC- 10076840529879 Consumer UPC - 7684052987 Paper carton 8 units per shrink-wrapped case Frozen
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0788-2017·2016-12-28

    Midwest International Corp Recalls Dried Vegetable Product

    Midwest International Corp is recalling dried vegetable products because they are acidified foods without a registered manufacturer or scheduled process.

    Product
    DRIED VEGETABLE, NET WT: 17.6oz (500g)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0823-2017·2016-12-28

    Stanmore Implants Recalls Punctured Femoral Stem Components

    Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.

    Product
    Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0880-2017·2016-12-28

    Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure

    Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.

    Product
    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0858-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Unsealed Packaging

    Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0863-2017·2016-12-28

    Biomet 3i Low Profile Abutment Titanium Retaining Screw Recall

    Biomet 3i is recalling 1,633 Low Profile Abutment Titanium Retaining Screws because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0825-2017·2016-12-28

    Philips Ingenia MR-OR Recalled for Potential Touch Current Exposure

    Philips is recalling nine Ingenia MR-OR units due to a possibility that patients or users may be exposed to a very small level of touch current.

    Product
    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0815-2017·2016-12-28

    Brownwood Farms Jalapeno Cherry Salsa Recalled for Undeclared Yellow 5

    Brownwood Farms is recalling Jalapeno Cherry Salsa because it contains Yellow 5, an ingredient not declared on the label.

    Product
    Brownwood Farms Jalapeno Cherry Salsa. 21oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Cherry Jalapeno Salsa 21oz). Kimmel Orchard & Vineyard.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0829-2017·2016-12-28

    Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect

    Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0787-2017·2016-12-28

    FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling

    Vygon MFG, Inc. is recalling 31,500 AMS-651 Microbore extension sets because the package displays an incorrect priming volume.

    Product
    AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0759-2017·2016-12-28

    Real Fudge Salted Caramel Fudge Recalled for Undeclared Blue #1

    Real Fudge is recalling Salted Caramel Fudge because the product contains undeclared Blue #1, a food dye.

    Product
    Salted Caramel Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0896-2017·2016-12-28

    Busse recalls surgical instrument trays containing recalled gloves

    Busse Hospital Disposables is recalling surgical instrument trays that contained recalled Covidien Devon Light Gloves.

    Product
    SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0821-2017·2016-12-28

    Stanmore Implants Recalls Tibial Components Due to Packaging Puncture

    Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.

    Product
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the…
    Category
    Medical Device
    Distribution
    Distributed nationwide