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.

15901–15925 of 21645

  • ModerateFDA (Devices)·Z-2352-2015·2015-08-19

    Merit Medical Recalls ReSolve Locking Drainage Catheters Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling 950 ReSolve Locking Drainage Catheters because the unit labeling may not match the actual device in the package.

    Product
    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2015·2015-08-19

    Sensodyne Complete Protection Recalled for Wood Fragments

    GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2949-2015·2015-08-19

    Mitsuwa Recalls Baked Seasoned Fish Products Due to Temperature Violation

    Mitsuwa Corporation is recalling specific baked seasoned fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Goby Okabe (Osakana Roll) Net Wt.: 65GR/2.29oz Ingredients: Goby, Sugar, Salt, Sorbitol, Monosodium Glutamate Keep Refrigerated SKU: 4 971455 081738 Product of Japan Exported By: KC Central Trading Co. Ltd. 4F 7-2 Irifune 3-Chome Chuo-Ku Tokyo…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1319-2015·2015-08-19

    Biotene Sodium Fluoride Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    BIOTENE — BIOTENE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2015·2015-08-19

    GE Laser Centering Device Recalled for Regulatory Non-Compliance

    GE Inspection Technologies is recalling 25 laser centering devices for X-ray generators due to potential failure to comply with federal regulations.

    Product
    GE Optional Laser Centering Device X-ray generator.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2376-2015·2015-08-19

    Biotronik Recalls Unapproved Pacemaker Programmer Software Versions

    Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.

    Product
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2380-2015·2015-08-19

    Boston Scientific Recalls AngioJet AVX Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet AVX Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2954-2015·2015-08-19

    Kraft American Singles Cheese Recalled for Plastic Film Contamination

    Kraft Heinz is recalling Kraft American Singles cheese slices because some may contain thin strips of plastic film on the edges.

    Product
    Kraft American Singles Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1 lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and blue lettering.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2941-2015·2015-08-19

    Janka Apricot Pierogi Recalled for Missing Yellow #5 Labeling

    Krusinskis Finest Meat Products is recalling Janka Fully Cooked Apricot Pierogi because Yellow #5 was not listed on the label.

    Product
    Janka Fully Cooked Apricot Pierogi Ingredients: DOUGH: Blended Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate, Thiamine Mononitrate, Riboflavin), Water, Whole Milk, Eggs, Dried Potatoes (Color and Flavor Protected with Sodium Bisulfate, Citric Acid and…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1320-2015·2015-08-19

    Biotene PBF Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene PBF toothpaste because wood fragments were found when the product was extruded.

    Product
    biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2955-2015·2015-08-19

    Kraft American Singles cheese recalled due to plastic film contamination

    Kraft Heinz is recalling specific Kraft American Singles cheese products because they may contain thin strips of plastic film on the edges of the slices.

    Product
    Kraft American Singles white American Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1324-2015·2015-08-19

    Sensodyne Toothpaste Recalled Due to Wood Fragments

    GlaxoSmithKline is recalling 325,504 tubes of Sensodyne toothpaste because wood fragments were found when the product was extruded.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1317-2015·2015-08-19

    Biotene Gentle Mint Gel Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene Gentle Mint Gel tubes because wood fragments were found in the product. Consumers should stop using the affected lots.

    Product
    biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2015·2015-08-19

    Stryker Recalls Mispackaged Orthopedic Shoulder Trial Instruments

    Stryker is recalling 21 units of a shoulder trial instrument because the package contained the wrong part number.

    Product
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2361-2015·2015-08-19

    Abbott Recalls i-Stat PT/INR Cartridges Due to Test Delays

    Abbott Point Of Care Inc. is recalling specific lots of i-Stat PT/INR Cartridges because they may generate excessive star outs, potentially delaying patient results.

    Product
    i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2015·2015-08-19

    Sensodyne Toothpaste Recalled Due to Wood Fragments

    GlaxoSmithKline is recalling Sensodyne toothpaste tubes because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2015·2015-08-19

    Biotene Fluoride Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene fluoride toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    BIOTENE — BIOTENE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2378-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Dates

    Boston Scientific is recalling 9 AngioJet SOLENT Omni Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2360-2015·2015-08-19

    Stryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement

    Stryker Howmedica Osteonics is recalling 26 Triathlon tibial inserts because one unit was found in a package labeled for a different catalog number.

    Product
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1300-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Documentation Issues

    The Apothecary Shoppe is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection vials because proper environmental monitoring documentation was missing during production.

    Product
    SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1316-2015·2015-08-12

    Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling S-Methylcobalamin 5000 mcg/mL Injection in 750 mL containers due to a lack of assurance of sterility.

    Product
    S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-2926-2015·2015-08-12

    La Jalpita Vanilla Bolis Recalled for Undeclared Yellow No. 6

    Paleteria La Jalpita is recalling 1,350 units of Vanilla bolis (tube) sold in Oregon and Washington due to undeclared Yellow No. 6.

    Product
    Vanilla bolis (tube), La Jalpita brand, 3.5 Fl oz., No UPC
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1991-2015·2015-08-12

    Olympus Analytical X-ray Systems Recalled for Higher Scatter Readings

    Olympus Scientific Solutions Americas is recalling 1,047 Analytical X-ray Systems because scatter readings around the probe head were higher than published specifications for certain samples.

    Product
    Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1308-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
    Category
    Drug
    Distribution
    1 state