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.

16026–16050 of 21645

  • ModerateFDA (Devices)·Z-2311-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 80 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2277-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2272-2015·2015-08-05

    Synthes Maxillary Plates Recalled for Incorrect Laser Etch Orientation

    Synthes (USA) Products LLC is recalling 31 pre-bent maxillary plates due to potential incorrect laser etch denoting orientation.

    Product
    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2230-2015·2015-08-05

    EXP Recalls Fiberwire Suture Scissors Due to Registration Violations

    EXP Pharmaceutical Services Corp is recalling Fiberwire Suture Scissors because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2299-2015·2015-08-05

    Anspach 7MM Fluted Acorn Dissection Tools Recalled for Labeling Inconsistency

    The Anspach Effort, Inc. is recalling 189 Anspach 7MM Fluted Acorn dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.

    Product
    ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Food)·F-2890-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Lactose Free American Cheese

    Dairy Farmers of America is recalling Borden Lactose Free American Cheese because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Pasteurized Prepared Cheese Product: BORDEN 12/8OZ LACTOSE FREE AMER YLW, 5300000902.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2234-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2287-2015·2015-08-05

    Anspach Fluted Barrel Dissection Tools Recalled for Labeling Inconsistency

    The Anspach Effort, Inc. is recalling 110 fluted barrel dissection tools because the labeled shaft exposure may be inconsistent with actual usage.

    Product
    ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2265-2015·2015-08-05

    Ivoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles

    Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.

    Product
    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-2885-2015·2015-08-05

    Dairy Farmers of America Recalls Shop Rite Non-Fat White Cheese

    Dairy Farmers of America is recalling Shop Rite non-fat white cheese because plastic film strips may remain attached to the slices.

    Product
    SHOP RITE 12/12OZ AMER NON-FAT WHITE, 4119045823
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2219-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Implantable Staple Loading Units

    EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2889-2015·2015-08-05

    Dairy Farmers of America Recalls Swiss Cheese Slices Due to Plastic Film

    Dairy Farmers of America is recalling Borden Swiss Singles cheese slices because plastic film strips may remain attached to the cheese.

    Product
    Pasteurized Prepared Cheese Product: BORDEN 12/8OZ SWISS SINGLES CHEESE PROD WHT, 5300000682.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2263-2015·2015-08-05

    McKesson Paragon Laboratory Management Software Recall for Data Display Errors

    McKesson Technologies is recalling Paragon Laboratory Management software versions 12.1 and 12.1.1 because the Final Cumulative Report may display incorrect data when used with Microsoft SQL Server 2012.

    Product
    Paragon Laboratory Management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 118 G1 dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.

    Product
    ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2210-2015·2015-08-05

    MTF Recalls Allograft Cortical Pins Due to Diameter Labeling Error

    Musculoskeletal Transplant Foundation is recalling one lot of Allograft Cortical Pins because the 2.0 mm label may contain 2.4 mm pins.

    Product
    Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2223-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Suction Devices

    EXP Pharmaceutical Services Corp is recalling sterile suction devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2296-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 103 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Food)·F-2905-2015·2015-08-05

    Rachael's Gourmet Candy Necklaces Recalled for Undeclared Food Dyes

    Consumer Product Distributors Inc. is recalling Rachael's Gourmet Candy Necklaces because they contain undeclared food dyes and mislabel one other.

    Product
    RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2239-2015·2015-08-05

    EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur

    EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2873-2015·2015-08-05

    Dairy Farmers of America Recalls Marvella American Cheese Due to Plastic Film

    Dairy Farmers of America is recalling Marvella American Pasteurized Cheese Singles because a piece of plastic film might remain attached to the cheese slice.

    Product
    American Pasteurized Cheese Product: MARVELLA 12OZ 340G AMERICAN PASTEURIZED CHEESE, SINGLES, 5193319275.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2227-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems

    EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2880-2015·2015-08-05

    Dairy Farmers of America Recalls American Cheddar Flavor Slices

    Dairy Farmers of America is recalling American Cheddar Flavor Slices because a piece of plastic film might remain attached to the cheese.

    Product
    American Cheddar Flavor Slices: SOYA KAAS 12/8OZ AMERICAN CHEDDAR FLAVOR SLICES, 7801600480.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2248-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations

    EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.

    Product
    Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    Category
    Medical Device
    Distribution
    6 states