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.

15201–15225 of 21645

  • ModerateFDA (Devices)·Z-0844-2016·2016-03-02

    Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion Issue

    Zimmer Biomet is recalling CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the polished implant surface.

    Product
    CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0698-2016·2016-03-02

    Bigwall WARM STEAM Personal Steam Inhaler Recalled for Unconfirmed Consumer Complaints

    Bigwall Enterprises is recalling WARM STEAM Personal Steam Inhalers nationwide due to unconfirmed consumer complaints. No causal link to product use has been established.

    Product
    WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues

    Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.

    Product
    Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2016·2016-03-02

    Zimmer Biomet Recalls CPT Hip Prostheses Due to Packaging Adhesion

    Zimmer Biomet is recalling 289 CPT 12/14 COCR hip prostheses because the LDPE packaging bag adheres to the implant surface.

    Product
    CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2016·2016-03-02

    Zimmer Biomet Recalls Metasul Head 40 Total Hip Prosthesis Components

    Zimmer Biomet is recalling 194 Metasul Head 40 total hip prosthesis components because the packaging bag adheres to the implant surface.

    Product
    Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0887-2016·2016-03-02

    Fresenius Naturalyte Liquid Acid Concentrate Recalled for Labeling Error

    Fresenius Medical Care is recalling Naturalyte Liquid Acid Concentrate because the label incorrectly lists the calcium concentration.

    Product
    Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0623-2016·2016-03-02

    Purple Cow Cookie Butter Ice Cream Recalled for Mislabeling

    House of Flavors is recalling Purple Cow Limited Edition Cookie Butter Ice Cream because the cups contain Butter Pecan ice cream instead.

    Product
    Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0847-2016·2016-03-02

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion

    Zimmer Biomet is recalling 101 Versus 7.5 inch hip prostheses because the LDPE packaging bag adheres to the implant surface.

    Product
    VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2016·2016-03-02

    Olympus Delta XRF Analyzer Recalled Due to Software Bug

    Olympus Scientific Solutions Americas is recalling Delta XRF Analyzers because the firm discovered a software bug.

    Product
    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0542-2016·2016-02-24

    Sunset Natural Products Recalls Prostamax DUO Dietary Supplement

    Sunset Natural Products Inc. is recalling 4,000 bottles of Prostamax DUO dietary supplements in Florida and Nevada pursuant to a consent decree.

    Product
    Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0808-2016·2016-02-24

    Leica Bond Polymer Refine Red Detection Kits Recalled for Staining Errors

    Leica Microsystems is recalling Bond Polymer Refine Red Detection kits due to a manufacturing error that may cause inadequate staining.

    Product
    Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0613-2016·2016-02-24

    Umpqua Dairy Lowfat Cottage Cheese Recalled for Antibiotic Residue

    Umpqua Dairy is recalling 1.5% lowfat cottage cheese because the milk used was presumptively positive for beta-lactam antibiotics.

    Product
    Pint Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04839, net wt. 16 oz. UPC 0 71203 00360 0. 3 lbs. Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04146, net wt. 3 lbs.. UPC 0 71203 00376 1.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0539-2016·2016-02-24

    Sunset Natural Products Recalls Moinsage Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Moinsage dietary supplement capsules pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.

    Product
    Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0602-2016·2016-02-24

    Umpqua French Vanilla Ice Cream Recalled for Presumptive Antibiotic Presence

    Umpqua Dairy Products Co is recalling French Vanilla Ice Cream because the milk used was tested presumptive positive for beta lactam antibiotics.

    Product
    Umpqua French Vanilla Ice Cream, Item no. 12750, 1.75 Quart container, UPC 0 71203 08751 8
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0612-2016·2016-02-24

    Umpqua Dairy Cottage Cheese Recalled for Presumptive Antibiotic Presence

    Umpqua Dairy is recalling 4% Cottage Cheese because the milk used was presumptively positive for beta-lactam antibiotics without confirmation testing.

    Product
    Pint Umpqua Dairy 4% Cottage Cheese, item no. 04308, Net wt. 16 oz. UPC 0 71203 00248 1 24 oz. Umpqua Dairy 4% Cottage Cheese, item no. 04286, UPC 0 71203 00255 9. 3 lbs. Umpqua Dairy 4% Cottage Cheese, item no. 03980, UPC 0 71203 00280 1.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0614-2016·2016-02-24

    Umpqua Dairy Nonfat Cottage Cheese Recalled for Antibiotic Residue

    Umpqua Dairy is recalling nonfat cottage cheese because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Pint Umpqua Dairy Nonfat Cottage Cheese, item no. 04847, Net wt. 16 oz., UPC 0 71203 00373 0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0590-2016·2016-02-24

    Kwik Trip Bakery Recalls Triple Choc Bismark Due to Plastic Contamination

    Kwik Trip Bakery is recalling Triple Choc Bismark products that may contain plastic pieces from contaminated ice nuggets. The recall affects products distributed in Wisconsin, Minnesota, and Iowa.

    Product
    Triple Choc Bismark 9999954048, 540484, 24 per bulk tote.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0620-2016·2016-02-24

    Red Diamond Coffee Concentrate Recalled for Elevated pH Levels

    Red Diamond, Inc. is recalling 136 units of Colombian Coffee Concentrate due to elevated pH levels in an acidified product.

    Product
    RED DIAMOND, COLOMBIAN, NATURALLY DECAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111591
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0611-2016·2016-02-24

    Sunshine Empress Vanilla Ice Cream Recalled for Presumptive Antibiotic Presence

    Umpqua Dairy Products Co is recalling 160 three-gallon containers of Sunshine Empress Vanilla Ice Cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Sunshine Empress Vanilla Ice Cream, item no. 12175, 3 gallon container. No UPC code.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0609-2016·2016-02-24

    Dairy Queen Chocolate Soft Serve Mix Recalled for Antibiotic Residue

    Umpqua Dairy Products is recalling Dairy Queen Chocolate Soft Serve Mix because the milk used was presumptively positive for beta-lactam antibiotics.

    Product
    Dairy Queen Chocolate Soft Serve Mix, item no. 04979, 5 gallon container. UPC 0071203004874
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0538-2016·2016-02-24

    Sunset Natural Products Recalls Chardon de Marie Dietary Supplement

    Sunset Natural Products is recalling Chardon de Marie dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0605-2016·2016-02-24

    Umpqua Peppermint Candy Ice Cream Recalled for Potential Antibiotic Residue

    Umpqua Dairy Products Co is recalling Peppermint Candy Ice Cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Umpqua Peppermint Candy Ice Cream, Item no. 12904, 1.75 quart container, UPC 0 71203 08793 8
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0603-2016·2016-02-24

    Umpqua Birthday Cake Ice Cream Recalled for Presumptive Antibiotic Presence

    Umpqua Dairy Products Co is recalling Birthday Cake Ice Cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Umpqua Birthday Cake Ice Cream, Item no. 12815, 1.75 quart container, UPC 0 71203 08793 8
    Category
    Food
    Distribution
    6 states