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.

11826–11850 of 53044

  • HighFDA (Food)·F-1472-2023·2023-09-06

    Moore Family Farms Cheddar Cheese Curds Recalled for Coliform and E. Coli Contamination

    Moore Family Farms and Creamery Cheddar Cheese Curds (1 lb plastic bags) are being recalled due to potential contamination with elevated coliform counts and E. coli. The recall affects 30 bags distributed in Iowa.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds, 1 lb plastic bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1108-2023·2023-09-06

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.

    Product
    CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2023·2023-09-06

    Del Monte Canned Fruit Recall Due to Improper Temperature Storage

    C & S Wholesale Grocers is recalling approximately 29,469 cases of Del Monte canned fruit products sold at Stop & Shop stores in NY, NJ, and CT because they were not held at appropriate temperatures during distribution.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Del Monte Red Grapefruit Del Monte Citrus Salad Del Monte Grapefruit No sugar added Del Monte Pears Del Monte Blueberry Parfait Del Monte Mandarine Orange Del Monte Peaches No Sugar Added Del…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1118-2023·2023-09-06

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Gaps

    Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2023·2023-09-06

    Oculus Myopia Master optical device recalled for insufficient anti-reflective coating

    Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.

    Product
    Oculus Myopia Master , Ref 68100, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1131-2023·2023-09-06

    EPINEPHrine IV bags recalled for sterility assurance failure

    Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.

    Product
    EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1124-2023·2023-09-06

    Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.

    Product
    PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1470-2023·2023-09-06

    Peanut Butter Mellow Mallow Recalled for Undeclared Soy and Coconut Allergens

    BURNING ACRE recalled Peanut Butter Mellow Mallow 7-ounce packages due to undeclared soy lecithin and coconut allergens. The affected product was distributed in Georgia and Tennessee.

    Product
    Peanut Butter Mellow Mallow packaged in 7oz cellophane wrappers.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2477-2023·2023-09-06

    FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results

    Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.

    Product
    epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Drugs)·D-1125-2023·2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1123-2023·2023-09-06

    Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2023·2023-09-06

    Olympus Bronchovideoscope Models Recalled Due to Lodging Risk in Connectors

    Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.

    Product
    Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1488-2023·2023-09-06

    Mehlenbacher's Taffy strawberry lemonade recalled for undeclared milk allergen

    Mehlenbacher's Taffy strawberry lemonade is being recalled due to an undeclared milk allergen. Consumers with milk allergies are at risk.

    Product
    Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Strawberry lemonade UPC 022099174035. Storage in a cool dry place.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2485-2023·2023-09-06

    Philips Wireless Foot Switch for X-Ray Systems Risks Loss of Function During Procedures

    Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.

    Product
    Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1467-2023·2023-09-06

    Dairy and Plant-Based Cheese Products Recalled for Improper Temperature Storage

    C & S Wholesale Grocers Inc. is recalling cheese and dairy alternative products sold at Stop & Shop stores in the New York Metro Region because they were not held at appropriate temperatures. Consumers should discard or return affected items.

    Product
    The following items sold at Stop & Shop stores located in the New York Metro Region: Galaxy Parmeson Topping Vitro Vegan Cheddar Shreds Vitro Cheddar Block Vitros Cheddar Slices Vitros Mozz Shreds Vitros vegan Feta Galaxy Cheddar Veggie Sliced Mozzarella Field Roast Chao…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2468-2023·2023-09-06

    Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect

    LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.

    Product
    The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2471-2023·2023-09-06

    Laboratory diagnostic test may produce inaccurate results from reagent carryover

    Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.

    Product
    Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2023·2023-09-06

    Phoroptor VRx Digital Refraction System head detachment hazard recall

    Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.

    Product
    PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1474-2023·2023-09-06

    Moore Family Farms Cheddar Cheese Curds Loaded Baked Potato Recalled for E. coli

    Moore Family Farms Creamery is recalling Cheddar Cheese Curds Loaded Baked Potato (1 lb bags) from Iowa due to possible E. coli and coliform contamination.

    Product
    Moore Family Farms and Creamery Cheddar Cheese Curds Loaded Baked Potato, 1 lb plastic bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2488-2023·2023-09-06

    Beckman Coulter IgA Diagnostic Reagent Recalled for Lipemic Test Interference

    Beckman Coulter is recalling approximately 12,850 units of IgA diagnostic reagent due to performance failures when testing lipemic blood samples, which could lead to inaccurate test results.

    Product
    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Drugs)·D-1132-2023·2023-09-06

    Sterile Injectable Drug Recall: oxyTOCIN in Lactated Ringer's IV Bags

    Central Admixture Pharmacy Services is recalling 1,996 bags of oxyTOCIN in Lactated Ringer's IV bags because the company cannot assure the products are sterile. The firm lacks validation data for its sanitization procedures.

    Product
    oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2023·2023-09-06

    Asmus Seasonings Asian Spice Blend recalled due to undeclared sesame allergen

    Asmus Seasoning, Inc. is recalling Asmus Seasonings Asian Spice Blend because the product contains undeclared sesame. Consumers with sesame allergies should not consume this product.

    Product
    Asmus Seasonings Asian Spice Blend 18oz clear plastic bottle, UPC 7 18122 95603 6, item number 233944, 12 bottle per wholesale case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1487-2023·2023-09-06

    Mehlenbacher's Watermelon Taffy recalled for undeclared milk allergen

    Mehlenbacher's Taffy in Watermelon flavor is being recalled due to undeclared milk allergen in the product. Consumers with milk allergies should not consume this product.

    Product
    Mehlenbacher's Taffy, 1.25 oz per piece, 36 pieces/box, cello wrapped. Watermelon UPC 022099174004. Storage in a cool dry place.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2490-2023·2023-09-06

    Olympus Bronchovideoscope models recalled for lodging risk in airway connectors

    Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.

    Product
    Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23E066000·2023-09-05

    Covercraft Seat Covers Recalled for Incorrect Air Bag Deployment Risk

    Covercraft is recalling specific seat covers for Toyota, Ford, and Buick vehicles because incorrect thread may cause side-seat air bags to deploy incorrectly, increasing injury risk.

    Product
    SEATS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide