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.

20451–20475 of 21633

  • ModerateFDA (Drugs)·D-442-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab tablets due to cGMP deviations and stability failures. The product was repackaged and distributed nationwide.

    Product
    Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1428-2013·2013-05-29

    Organic Apple Juice Recalled for Patulin Contamination

    Clement Pappas & Co. is recalling specific lots of Nature's Promise Organic Apple Juice because the apple juice concentrate ingredient contained patulin levels between 57.4 and 100 ppb.

    Product
    1) Organics Nature's Promise Organic Apple Juice 64 FL OZ (2 QT) 1.89L UPC 688267036156 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 2) Organics Nature's Promise Organic Apple Juice 6.75 FL OZ (200 mL) UPC 688267063107 Distributed by…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2013·2013-05-22

    Insight Instruments Recalls M.I.S. Ophthalmic Cannulas Due to Misclassification

    Insight Instruments is recalling 776 M.I.S. Ophthalmic Cannulas distributed in Indiana and Illinois because the device was misclassified.

    Product
    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas.…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1295-2013·2013-05-22

    HeliPlug Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2013·2013-05-22

    Integra Recalls CollaPlug Collagen Wound Dressings Due to Pyrogen Levels

    Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2013·2013-05-22

    Curity Staple Remover Kit Recalled Due to Supplier OTC Drug Issue

    Covidien is recalling Curity Staple Remover Kits because a supplier recalled OTC drug products used in the kits.

    Product
    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1394-2013·2013-05-22

    Grove Grow Notes Hawthorne Recalled for Unapproved Food Dyes

    S & M International Inc is recalling Grove Grow Notes Hawthorne because it contains unapproved dyes Ponceau 4R and FD&C Yellow #5.

    Product
    Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1330-2013·2013-05-22

    Bio-Rad Recalls Liquichek ToRCH Plus IgM Control Due to HCV RNA

    Bio-Rad is recalling Liquichek ToRCH Plus IgM Control - Positive because it contains detectable levels of HCV RNA originating from the manufacturing process.

    Product
    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1395-2013·2013-05-22

    Tasty Snacks Sour Plum Recalled for Undeclared Sulfites and Unallowed Dye

    S & M International Inc. is recalling Tasty Snacks Sour Plum in New York due to undeclared sulfites, unallowed dye, and undeclared colorant.

    Product
    Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1282-2013·2013-05-22

    Integra Recalls DuraGen Dural Graft Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling DuraGen Dural Graft Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1334-2013·2013-05-22

    Becton Dickinson Recalls CDC Anaerobe 5% Sheep Blood Agar Due to Contamination

    Becton Dickinson is recalling BBL CDC Anaerobe 5% Sheep Blood Agar because the microbiological media may be contaminated with bacteria.

    Product
    BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1396-2013·2013-05-22

    Lam Sheng Kee Mini Sausage Recalled for Undeclared Ingredients

    S & M International Inc. is recalling Lam Sheng Kee Mini Sausage Hong Kong Style due to undeclared FD&C Red #40 and minced fish.

    Product
    Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1333-2013·2013-05-22

    Becton Dickinson Recalls Trypticase Soy Agar and MacConkey II-I Plates

    Becton Dickinson & Co. is recalling specific lots of Trypticase Soy Agar and MacConkey II-I plates due to potential bacterial contamination.

    Product
    BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2013·2013-05-22

    Karl Storz Cutting Loops Recalled for Packaging Damage

    Karl Storz is recalling 9,432 cutting loops due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1305-2013·2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1387-2013·2013-05-22

    Hokkai Frozen Half Shell Oysters Recalled for Insanitary Conditions

    Hong Chang Corporation is recalling Hokkai Frozen Half Shell Oysters because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Hokkai Frozen Half Shell Oyster, 144 pcs/case.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1287-2013·2013-05-22

    Integra NeuraGen Nerve Guide Recalled for Pyrogen Deviation

    Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-331-2013·2013-05-22

    Glenmark Recalls Topiramate Tablets Due to Off-Odor Complaints

    Glenmark Generics Inc. is recalling Topiramate Tablets due to complaints of a moldy, musty, or fishy odor. The recall covers 9,624 bottles distributed nationwide.

    Product
    TOPIRAMATE — TOPIRAMATE (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2013·2013-05-22

    Summit Medical Recalls Myringotomy Lance Blades Due to Incorrect Packaging

    Summit Medical is recalling Myringotomy Lance Blades because the boxes contain the wrong type of blade.

    Product
    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1329-2013·2013-05-22

    Medtox Diagnostics Recalls PROFILE-V MEDTOXScan Drugs of Abuse Test System

    Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.

    Product
    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1308-2013·2013-05-22

    Karl Storz Recalls Sterile Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging may allow airborne contamination.

    Product
    Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1328-2013·2013-05-22

    Iris Diagnostics Recalls iQ Control/Focus Sets Due to Performance Issues

    Iris Diagnostics is recalling iQ Control/Focus Sets because customer complaints indicated the product failed to meet performance specifications, preventing patient sample testing.

    Product
    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2013·2013-05-22

    Karl Storz VaporCut Electrode Recalled for Packaging Damage

    Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2013·2013-05-22

    American Medical Systems Recalls AMS 800 Urinary Control System Components

    American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled…
    Category
    Medical Device
    Distribution
    Distributed nationwide