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.

9576–9600 of 22202

  • HighFDA (Food)·F-0078-2025·2024-11-06

    Bistro 28 Chicken Enchilada Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Bistro 28 Creamy Green Chile Chicken Enchilada Meal Kits due to Listeria monocytogenes contamination in the cooked chicken. The affected meal kits were distributed across 30 U.S. states.

    Product
    Item 407118, UPC 13454 38493, Bistro 28 Creamy Green Chile Chicken Enchilada Express Meal Kit. Make 6 Enchiladas. Ready in 5 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384937, Case UPC 13454 38493, Bistro 28 Creamy Gre
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0266-2025·2024-11-06

    Medical Diagnostic Stain Product Recalled for Out-of-Specification Color Change

    Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange after discovery that the solution can change color during use, resulting in out-of-specification fluorescent staining results.

    Product
    remel BactiDrop Acridine Orange, REF 21502, 50 per package.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0092-2025·2024-11-06

    Reser's Asian Style Stir Fry Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling 420 cases of Asian Style Stir Fry meal kits containing potentially contaminated cooked chicken due to Listeria monocytogenes. Affected products were distributed across 30 states with Use By dates from September through November 2024.

    Product
    Item 406897,UPC 13454 38407, Asian Style Stir Fry Single Serve OP no Trays 1/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0081-2025·2024-11-06

    Chicken Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods recalled Bistro 28 Chicken Street Tacos Express Meal Kits due to Listeria monocytogenes in the cooked chicken. The recall affects 2,880 cases distributed across 31 states.

    Product
    Item 407120, UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Meal Kit. Made 6 Tacos. Ready in 3 MIN. Net wt. 22 oz (1 LB 6 OZ) 624g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384951, Case UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Mea
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.

    Product
    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels in raw materials

    Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2025·2024-11-06

    Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.

    Product
    SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0071-2025·2024-11-06

    Glaser Organic Farms Salsa Recalled for Possible Glass Contamination

    Glaser Organic Farms recalls All Raw Vegan Certified Organic Salsa due to potential glass contamination. The product may pose a risk of injury to consumers.

    Product
    All Raw Vegan Certified Organic Salsa, Glaser Organic Farms, Handmade fresh from our farm to you,Net wt. 8 oz, Plastic PET Container with cover, Keep Refrigerated, UPC 832910 001514
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0279-2025·2024-11-06

    Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings

    The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.

    Product
    AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0234-2025·2024-11-06

    Abbott STI and HPV Test Kits Recalled for Quality Control Failures

    Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.

    Product
    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0256-2025·2024-11-06

    Surgical Patties and Strips recalled for endotoxin contamination in raw materials

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.

    Product
    SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2025·2024-11-06

    Abbott Alinity m HPV test kit control failures from iron contamination

    Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.

    Product
    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2025·2024-11-06

    OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration

    BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.

    Product
    CHLORPHENIRAMINE MALEATE 4MG — CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0247-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.

    Product
    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2025·2024-11-06

    Pregnancy Test Kits Recalled for False Negative Results

    Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.

    Product
    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0079-2025·2024-11-06

    Reser's Chicken Quesadilla Meal Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Bistro 28 Chicken Quesadilla Express Meal Kits distributed across 30 states due to potential Listeria monocytogenes contamination in the cooked chicken.

    Product
    Item 407121, UPC 13454 38496, Bistro 28 Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384968, Case UPC 13454 38496, Bistro 28 Chicken Quesadilla Expres
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0091-2025·2024-11-06

    Asian Style Chicken Stir Fry Kit recalled for Listeria monocytogenes

    Reser's Fine Foods recalled Asian Style Chicken Stir Fry Kits distributed by Fresh Creative Foods due to Listeria monocytogenes contamination in the cooked chicken. 192 cases were distributed across 30 US states.

    Product
    Item 406740, UPC 13454 38316, Asian Style Chicken Stir Fry Kit On Premise With Trays 2/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0249-2025·2024-11-06

    Surgical patties and strips recalled for endotoxin contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2025·2024-11-06

    Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk

    Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.

    Product
    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0080-2025·2024-11-06

    Bistro 28 Chicken Burrito Bowl Express Meal Kit recalled for Listeria

    Reser's Fine Foods is recalling Bistro 28 Chicken Burrito Bowl Express Meal Kits distributed across 31 states due to Listeria monocytogenes contamination in the cooked chicken. No illnesses have been reported.

    Product
    Item 407119, UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. Ready in 5 MIN. Net wt. 25 oz (1 LB 9 OZ) 788g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384944, Case UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. 4/25oz.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0275-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication

    King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.

    Product
    KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
    Category
    Medical Device
    Distribution
    Distributed nationwide