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.

21376–21400 of 21633

  • ModerateFDA (Devices)·Z-2119-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1436-2012·2012-08-08

    Watson Recalls Caziant Tablets Due to High Impurity Levels

    Watson Laboratories is recalling Caziant tablets because high levels of impurities were detected. Consumers should stop using the product and contact their healthcare provider.

    Product
    Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2012·2012-08-08

    Exactech Recalls Orthopedic Devices Due to Incorrect Shelf Life Labeling

    Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2110-2012·2012-08-08

    Beekley A-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 32,640 units of A-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1432-2012·2012-08-08

    Cadence Pharmaceuticals Recalls OFIRMEV Acetaminophen Injection Due to Particulate Matter

    Cadence Pharmaceuticals is recalling OFIRMEV (acetaminophen) injection vials due to the visible presence of particulate matter.

    Product
    OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2012·2012-08-08

    ICU Medical Recalls Cardiac Catheterization Waste Management Systems

    ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.

    Product
    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1814-2012·2012-08-08

    Defense Nutrition Organic Warrior Whey Powder Recalled for Undeclared Soy

    Defense Nutrition is recalling Organic Warrior Whey Powder, Plain, because it contains undeclared soy lecithin. The product was distributed in 23 states and Canada.

    Product
    Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA.
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Food)·F-1813-2012·2012-08-08

    Defense Nutrition Warrior Whey Powder Recalled for Undeclared Soy Lecithin

    Defense Nutrition is recalling Warrior Whey Natural Powder because it contains undeclared soy lecithin, a common allergen.

    Product
    Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case.
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2117-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.

    Product
    Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2114-2012·2012-08-08

    Aesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching

    Aesculap Implant Systems LLC is recalling 5 SIBD trial implants because the part numbers etched on the instruments may be incorrect, potentially causing selection errors.

    Product
    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2012·2012-08-08

    Advanced Sterilization Products Recalls STERRAD Biological Indicators Due to Shelf-Life Data Gaps

    Advanced Sterilization Products is recalling specific lots of STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the product's full labeled shelf-life.

    Product
    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2012·2012-08-08

    Beekley S-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 36,518 units of S-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1811-2012·2012-08-08

    Nestle Nesquik Chocolate Powder Recalled for Metal Fragment Contamination

    Nestle USA is recalling specific batches of Nesquik Chocolate Flavor beverage powder due to potential contamination with metal fragments.

    Product
    Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:"***Nestle Nesquick Chocolate FLAVOR*** NET WT***48.7OZ***DISTRIBUTED BY***NESTLE USA, INC., GLENDALE, CA 91203 USA***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2122-2012·2012-08-08

    Steris Reliance 130 Cart Washer Recall for Door Safety Feature Installation

    Steris is recalling 367 Reliance 130 and 130L Cart Washers to install a door close confirmation button and door open delay to ensure proper operation.

    Product
    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2012·2012-08-08

    Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

    Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.

    Product
    INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2103-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2012·2012-08-08

    Beekley O-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 267,332 units of O-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2012·2012-08-08

    GE OEC Medical Systems Recalls UroView 2800 Imaging Devices

    GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.

    Product
    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2116-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1438-2012·2012-08-08

    West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.

    Product
    FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1439-2012·2012-08-08

    Apotex Recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution Due to Particulates

    Apotex Inc. is recalling specific lots of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution because they may contain small particulates.

    Product
    Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2118-2012·2012-08-08

    Exactech Recalls Shoulder and Spine Devices Due to Labeling Error

    Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts qualified for five years.

    Product
    Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2115-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2112-2012·2012-08-08

    Beekley Altus Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 6,420 units of Altus Floral Skin Markers because the marker may separate from the backing material.

    Product
    Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1431-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide