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.

17676–17700 of 21645

  • ModerateFDA (Devices)·Z-0114-2015·2014-10-29

    Arrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components

    Arrow International is recalling 300 units of an epidural anesthesia kit because the kit contains a Luer-Lock syringe instead of the labeled Luer-Slip syringe.

    Product
    ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D0031-2015·2014-10-29

    New Gpc Inc. Recalls Mustarcreme for Labeling and Listing Deficiencies

    New Gpc Inc. is recalling Mustarcreme units in New York because the product lacks required drug listings, OTC labeling, and is marked not approved for U.S. sale.

    Product
    MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0108-2015·2014-10-29

    St. Jude Medical Recalls Fast-Cath Trio Hemostasis Introducer Due to Dilator Defect

    St. Jude Medical is voluntarily recalling 220 units of the Fast-Cath Trio Hemostasis Introducer because the dilator is too small to allow guidewire advancement, potentially causing procedural delays.

    Product
    St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0050-2015·2014-10-29

    Golden Corral Meatloaf Mix Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling Golden Corral Meatloaf Mix because the eggs used in the product are susceptible to premature spoilage.

    Product
    Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0099-2015·2014-10-29

    Intra Pump Infusion Systems Recalls CRN Crono Syringes Due to Needle Debris

    Intra Pump Infusion Systems is recalling CRN Crono Syringes because the needle tips may contain clear debris. The recall affects 25,440 units distributed in the US and Canada.

    Product
    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0118-2015·2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2015·2014-10-29

    ZEE Aspirin Recalled for Incorrect Inactive Ingredient Labeling

    ZEE Medical is recalling ZEE Aspirin 325mg tablets because the product label incorrectly lists inactive ingredients.

    Product
    ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2015·2014-10-29

    Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects

    Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.

    Product
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps…
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Drugs)·D0034-2015·2014-10-29

    New GPC Inc. Recalls Whitfield's Ointment for Labeling Deficiencies

    New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.

    Product
    Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0078-2015·2014-10-29

    Wild'erb Seasoning Recalled for Potential Illegal Sassafras Ingredient

    Ohio Valley Herbal Products is recalling Wild'erb Seasoning because it may contain sassafras leaves, an ingredient flagged as potentially illegal by the Ohio Department of Agriculture.

    Product
    Wild'erb Seasoning 2 oz and 4 oz plastic jars; seasoning contained less than 1% sassafras leaves.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0122-2015·2014-10-29

    Siemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 1000 Cortisol Assay reagents due to confirmed positive bias on controls.

    Product
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2015·2014-10-29

    Estill Medical Recalls Ultra Battery 1 for Insufficient Charging Capacity

    Estill Medical Technologies is recalling 6,886 Ultra Battery 1 units because they may not reach full charge capacity within the standard 60-minute charging period.

    Product
    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0055-2015·2014-10-29

    Ovation Brands Bead Pudding Base Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling Ovation Brands Bead Pudding Base because the eggs used in the product are susceptible to premature spoilage.

    Product
    Ovation Brands Bead Pudding Base #67008, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D0030-2015·2014-10-29

    New GPC Inc. Recalls Alcosulph Astringent Lotion for Labeling Deficiencies

    New GPC Inc. is recalling Alcosulph Astringent Lotion because it lacks required drug listings and OTC labeling, and is labeled as not approved for sale in the U.S.

    Product
    alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0070-2015·2014-10-22

    KCI Recalls V.A.C. GranuFoam Silver Dressing Due to Expiry Date Error

    KCI USA, Inc. is recalling V.A.C. GranuFoam Silver Dressing because some sterile pouches display an incorrect expiry date.

    Product
    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0044-2015·2014-10-22

    Coviden Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Coviden LLC is recalling 9,850 pairs of Medi-Trace Cadence defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.

    Product
    Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist One Vessel Sealer for Labeling and Software Issues

    Intuitive Surgical is voluntarily correcting labeling and software for the EndoWrist One Vessel Sealer used with the da Vinci Si Surgical System.

    Product
    EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 320 kits of the ArcPoint Labs 10 Panel Dip Screen (OXY) because the positive interpretation illustration on the cap labels and package insert was incorrect.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0022-2015·2014-10-22

    Kraft Recalls American Cheese Slices Due to Ingredient Storage Issue

    Kraft Heinz Foods is voluntarily recalling 7,691 cases of American cheese slices because a supplier failed to store an ingredient at the correct temperature.

    Product
    Individually 2/3 oz. slices of American cheese product individually wrapped in transparent plastic an packaged in 12 oz. and 16 oz.. packages, and 4 lb. cartons under the Kraft brand name. Cases of 12 oz. packages include 48 packages per case. Cases of 16 oz. packages…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2015·2014-10-22

    Valeant Recalls Subpotent Hydrocortisone Butyrate Cream 0.1% Tubes

    Valeant Pharmaceuticals is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1% because the product failed stability testing for potency and preservative levels.

    Product
    Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2015·2014-10-22

    Valeant Recalls Subpotent Locoid Hydrocortisone Butyrate Cream Tubes

    Valeant Pharmaceuticals is recalling 1,663 tubes of Locoid cream because the active ingredient and preservatives were subpotent at the 18-month stability test point.

    Product
    Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0064-2015·2014-10-22

    Roche Omni Micro-electrode Recall for Inconsistent Reference Values

    Roche Diagnostics is recalling Omni Micro-electrodes for the cobas b221 analyzer because default reference values are inconsistent with other instruments and instructions.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 5 Panel Dip Drug Screen Due to Labeling Error

    Ameditech is recalling 400 kits of the ArcPoint Labs 5 Panel Dip Drug Screen because the positive interpretation illustration on the labels and package insert was incorrect.

    Product
    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0023-2015·2014-10-22

    Gyma Recalls Clonidine Base Micronized Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Clonidine Base Micronized due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
    Category
    Drug
    Distribution
    Distributed nationwide