The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

12351–12375 of 53080

  • HighFDA (Drugs)·D-0994-2023·2023-08-09

    Neonatal TPN Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 68 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2023·2023-08-09

    Zimmer Periarticular Locking Plate recalled due to thread form defect

    Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.

    Product
    Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-1043-2023·2023-08-09

    Fentanyl injection syringes recalled for unvalidated sterilization process

    Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

    Product
    fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1044-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1335-2023·2023-08-09

    Sweetened Cranberries Recalled Due to Undeclared Allergen Cross Contamination

    Houston Pecan Company is recalling 5-pound bags of Sweetened Cranberries purchased before May 25, 2023. Product may contain undeclared tree nuts, peanuts, and wheat due to cross contamination. Distributed in Texas and via internet.

    Product
    Cranberries Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2326-2023·2023-08-09

    FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure

    Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1074-2023·2023-08-09

    Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns

    CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.

    Product
    lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0962-2023·2023-08-09

    FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.

    Product
    phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1308-2023·2023-08-09

    Caesar Pasta Salad Recall: Undeclared Wheat, Milk, Soybean

    Eat Good LLC recalls Caesar Pasta Salad for undeclared wheat, milk, and soybean allergens. Affected products were distributed in Idaho, Montana, and Washington.

    Product
    Caesar Pasta Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Caesar Pasta…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1060-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.

    Product
    HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2023·2023-08-09

    SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may cause procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1047-2023·2023-08-09

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1063-2023·2023-08-09

    Fentanyl Injectable Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0990-2023·2023-08-09

    Potassium Phosphate IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling potassium phosphate intravenous bags due to lack of sterility assurance and missing validation data for decontamination processes. The recall affects 234 bags distributed nationwide.

    Product
    potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1312-2023·2023-08-09

    Mediterranean Salad Recalled for Undeclared Allergens Including Milk

    Eat Good LLC is recalling Mediterranean Salad distributed in Idaho, Montana, and Washington due to missing allergen declarations for milk, sulfites, and FD&C Yellow #5.

    Product
    Mediterranean Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Mediterranean…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1340-2023·2023-08-09

    Breakfast Treats Recall: Potential Undeclared Allergen Contamination

    Houston Pecan Company is recalling 5-pound bags of Breakfast Treats with Almonds, Walnuts & Dark Raisins due to potential undeclared peanuts, wheat, and tree nuts from cross-contamination. Affected products were purchased before May 25, 2023, and sold in Texas and online.

    Product
    Breakfast Treats, Sliced Almonds, Walnuts & Dark Raisins packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V560000·2023-08-08

    Hino Recalls 2020-2024 Conventional Models for Fuel Gauge Defect

    Hino is recalling 8,025 vehicles because a fuel sensor defect may cause inaccurate readings, leading to unexpected stalling and increased crash risk.

    Product
    HINO — HINO CONVENTIONAL MODELS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V558000·2023-08-07

    Forest River Recalls 2023 Pause Travel Trailers Due to Awning Defect

    Forest River is recalling 2023 Pause travel trailers because the awning may not be adequately secured, posing a risk of injury or crash if it detaches.

    Product
    FOREST RIVER — FOREST RIVER PAUSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V559000·2023-08-07

    2024 Forest River Sierra and Sandpiper Braking System Defect

    Forest River is recalling certain 2024 Sierra and Sandpiper fifth wheels due to backwards axle installation that reduces braking ability and increases crash risk. Dealers will reinstall the axle at no cost.

    Product
    FOREST RIVER — FOREST RIVER SANDPIPER, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-080723-01·2023-08-07

    USDA Alerts on Fresh Salads and Wraps with Possible Lettuce Contamination

    USDA FSIS issued a public health alert for Fresh Seasons Kitchen salads and wraps due to possible deer feces contamination in lettuce.

    Product
    FSIS Issues Public Health Alert for Fresh Salads and Wraps with Meat and Poultry due to Possible Lettuce Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08042023-01·2023-08-04

    USDA Issues Public Health Alert for Raw Beef Due to Plastic Contamination

    USDA FSIS issued a public health alert for raw beef products that may contain soft, clear plastic. Consumers are urged not to consume the product.

    Product
    Cargill Meat Solutions Corporation — FSIS Issues Public Health Alert for Raw Beef Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V556000·2023-08-04

    2024 Hyundai Tucson Recalled for Incorrect Tire Information Label

    The tire and loading information label on 2024 Hyundai Tucson vehicles may provide incorrect spare tire information, potentially causing confusion during emergency tire replacement.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide