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.

12201–12225 of 21617

  • ModerateFDA (Devices)·Z-2755-2017·2017-08-02

    Medtronic Visualase Cooled Laser Applicator System Recalled for Seal Defect

    Medtronic is recalling 214 units of the Visualase Cooled Laser Applicator System because the cap may fail to seal, causing saline leaks.

    Product
    Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0984-2017·2017-07-26

    Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities

    Teva Pharmaceuticals is recalling Buprenorphine and Naloxone Sublingual Tablets because test results showed out-of-specification impurities.

    Product
    Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2745-2017·2017-07-26

    Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers

    Pentax Medical is recalling 241 laryngeal strobe systems because they were not always provided with required 9175 isolation transformers.

    Product
    9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2743-2017·2017-07-26

    Pentax 9310HD Digital Video Capture Modules Recalled for Missing Transformers

    Pentax of America is recalling 241 units of 9310HD Digital Video Capture Modules because they were not always provided with required 9175 isolation transformers.

    Product
    9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2754-2017·2017-07-26

    Merge Eye Care PACS Viewer 5.2 Recalled for Incorrect Image Sorting

    Merge Healthcare is recalling 18 units of Merge Eye Care PACS Viewer 5.2 due to a software defect that may cause incorrect study indexing and image misidentification.

    Product
    Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-2463-2017·2017-07-19

    3CS Organics Recalls HIPP Infant Formula Due to Labeling Issues

    3CS Organics LLC is recalling HIPP infant formula products because they are not FDA approved and lack full English labeling.

    Product
    HIPP HA Combiotik HA 1, 500g (4/case), HIPP Combiotik HA 2, 500g (4/case), HA Combiotik Pre HA, 500g (4/case), HIPP Combiotic Growing Up Milk 3, 600g (4bx/case)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2514-2017·2017-07-19

    Frozen Cheese Sauce with Macaroni and Green Beans Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen cheese sauce with macaroni and green beans due to water contaminated with PFOA and PFOS exceeding EPA health advisory levels.

    Product
    Item 12704 - CHEESE SAUCE WITH MACARONI AND GREEN BEANS>24EA/CS, Frozen, Net. Wt. 26.41 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2510-2017·2017-07-19

    Correctional Industries Recalls Turkey Ham Lunch Due to Chemical Contamination

    Correctional Industries Food Factory is recalling frozen Turkey Ham Lunch trays because they were made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 11952 - TURKEY HAM LUNCH>36 TRAYS/CS, Frozen, Net. Wt. 24.76 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2522-2017·2017-07-19

    Correctional Industries Recalls Vegan Chili Due to Chemical Contamination

    Correctional Industries Food Factory is recalling frozen vegan chili with macaroni and green beans because it was made with water contaminated with PFOA and PFOS.

    Product
    Item 14602 - VEGAN CHILI WITH MACARONI AND GREEN BEANS>24EA/CS, Frozen, Net. Wt. 26.41 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2711-2017·2017-07-19

    Toshiba APLIO 500 Ultrasound Systems Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.

    Product
    APLIO 500 TUS-A500 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2486-2017·2017-07-19

    Frozen Whole Wheat Dinner Rolls Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen white whole wheat dinner rolls because they were made with water contaminated with PFOA and PFOS.

    Product
    Item 10312 - WHITE WHOLE WHEAT DINNER ROLLS, BULK>96CT/CS, Frozen, Net. wt. 10.8 lbs. per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2474-2017·2017-07-19

    Frozen Turkey Ham Lunch Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen turkey ham lunch trays made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 11952 - TURKEY HAM LUNCH>36 TRAYS/CS, Frozen, Net. Wt. 24.76 lbs.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2500-2017·2017-07-19

    Frozen Halal Turkey Lunch Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen Halal Turkey Lunch trays because they were made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 10880 - HALAL TURKEY LUNCH>36 TRAYS/CS, Frozen, Net Wt. 20.36 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2492-2017·2017-07-19

    Frozen Whole Grain Chocolate Chip Muffins Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen whole grain chocolate chip muffins made with water contaminated by PFOA and PFOS chemicals.

    Product
    Item 10447 - WHOLE GRAIN CHOCOLATE CHIP MUFFINS, I/W>100CT/CS, Frozen, Net Wt. 13.89 lbs. per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2527-2017·2017-07-19

    Frozen Vegan Cajun Black Beans Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen vegan black beans, rice, and corn due to water contaminated with PFOA and PFOS chemicals.

    Product
    Item 14612 - VEGAN CAJUN STYLE BLACK BEANS, RICE AND CORN>24EA/CS, Frozen, Net. Wt. 30.31 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2483-2017·2017-07-19

    Frozen Chocolate Cupcakes Recalled Due to Chemical Contamination

    Correctional Industries Food Factory is recalling frozen chocolate cupcakes made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 10241 - CHOC CUPCAKES, I/W, NO ICING>100-CT/CS, Frozen, Net Wt. 13.89 lbs. per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2517-2017·2017-07-19

    Frozen Breakfast Burritos Recalled for Chemical Contamination in Water

    Correctional Industries Food Factory is recalling frozen breakfast burritos because they were made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 12735 - BREAKFAST BURRITO WITH RANCHERO SAUCE AND SWEET RICE>24EA/CS, Frozen, Net. Wt. 26.33 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2524-2017·2017-07-19

    Frozen Vegan Spaghetti and Lentils Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen vegan spaghetti and lentils because they were made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 14606 - VEGAN SPAGHETTI, AND COOKED LENTILS>24EA/CS, Frozen, Net. Wt. 33.76 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2509-2017·2017-07-19

    Frozen Turkey Lunch Recalled for Chemical Contamination in Water

    Correctional Industries Food Factory is recalling frozen turkey lunch trays because they were made with water contaminated with PFOA and PFOS.

    Product
    Item 11948 - TURKEY LUNCH>36 TRAYS/CS, Frozen, Net. Wt. 24.84 lbs. per case
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2494-2017·2017-07-19

    Frozen Banana Breakfast Bars Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen banana breakfast bars made with water contaminated by PFOA and PFOS chemicals.

    Product
    Item 10532 - BANANA BREAKFAST BARS, I/W>100CT(2.9OZ)/CS, Frozen, Net Wt. 18.13 lbs. per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2490-2017·2017-07-19

    Frozen Whole Grain Apple Chunk Muffins Recalled for Chemical Contamination

    Correctional Industries Food Factory is recalling frozen whole grain apple chunk muffins made with water contaminated by PFOA and PFOS chemicals.

    Product
    10437 - WHOLE GRAIN APPLE CHUNK MUFFINS, I/W>100CT/CS, frozen, Net Wt. 13.65 lbs. per case.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2706-2017·2017-07-19

    Fujifilm Recalls Ultrasonic Endoscope Model EG-530UT

    Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.

    Product
    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2526-2017·2017-07-19

    Frozen Vegan Burritos Recalled for Chemical Contamination in Water

    Correctional Industries Food Factory is recalling frozen vegan burritos made with water contaminated with PFOA and PFOS chemicals.

    Product
    Item 14610 - VEGAN RICE AND BEAN BURRITO, CHUNK ROAST POTATOES AND CORN>24EA/CS, Frozen, Net. Wt. 24.68 lbs. per case
    Category
    Food
    Distribution
    5 states