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.

17776–17800 of 50404

  • HighFDA (Devices)·Z-0797-2022·2022-03-23

    Lumbar Puncture Tray Devices Recalled for Manometer Leaking and Mating Issues

    Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.

    Product
    SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2022·2022-03-23

    Hologic Panther Fusion Extraction Reagent-X May Produce False Test Results

    Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.

    Product
    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2022·2022-03-23

    JAGTOME RX medical device recalled for sterile barrier breach

    Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.

    Product
    JAGTOME RX 39-20-450-025 Material Number: M00573090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0660-2022·2022-03-23

    Trimix Injectable Vials Recalled for Lack of Sterility Assurance

    Family Pharmacy of Statesville is recalling Trimix injectable vials (Alprostadil/Papaverine/Phentolamine 20 mcg/30 mg/0.5 mg) due to lack of assurance of sterility. The recall affects 2 vials distributed in North Carolina.

    Product
    Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0775-2022·2022-03-23

    Boston Scientific JAGTOME RX device recalled for sterile barrier breach

    Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.

    Product
    JAGTOME RX 44-30-260-035 Material Number: M00573060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2022·2022-03-23

    BioPlex 2200 Syphilis Calibrator Set Recall Due to Vaccine Interference and Reagent Stability Issues

    Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.

    Product
    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0869-2022·2022-03-23

    Honey BBQ seasoning recalled due to undeclared wheat allergen

    PS Seasoning & Spices recalls Honey BBQ Snack seasoning (3,001 units) distributed to 28 states and Canada due to undeclared wheat. Consumers with wheat allergies should not use affected lots.

    Product
    Honey BBQ Snack, NO MSG Seasoning packaged in the following sizes: 1. 685-A, Net Wt 21 lbs. (9.52kg). Part #020001456. 2. 685-B, Net Wt 5.25 lbs. (2.38kg). Part #020001457. Ingredients: Sugar, Salt, Dried Honey, Spices, Brown Sugar, Onion and Garlic Powder…
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-0879-2022·2022-03-23

    Port City Soups Baton Rouge Beans Recalled for Improper Acidification Process

    Port City Soups Baton Rouge Beans in 32-oz glass jars are being recalled due to an unapproved production process for acidified foods. The recall affects products sold in Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    Port City Soups Baton Rouge Beans 32oz glass mason jar sold by individual unit
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0881-2022·2022-03-23

    Stutzman Farms Sprouted Einkorn Grate Nuts recalled for undeclared wheat

    Stutzman Farms is recalling Sprouted Einkorn Grate Nuts for undeclared wheat content. Consumers with wheat allergies should not consume this product.

    Product
    Stutzman Farms Sprouted Einkorn Grate Nuts sold in .75lb and 3lb bags
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0795-2022·2022-03-23

    Lumbar Puncture Tray Adult recalled due to manometer failure and leaking

    Bard Peripheral Vascular Inc is recalling 8,630 lumbar puncture trays due to manometer failure causing leaking and mating issues. Devices were distributed nationwide in the U.S. plus Puerto Rico, Costa Rica, and Hong Kong.

    Product
    LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0892-2022·2022-03-23

    Plant-Based Chicken Chipotle Pasta Salad Kit Recalled for Plastic Contamination

    Fresh Creative Foods is recalling Plant Based Chicken Chipotle Pasta Salad Kit due to hard plastic pieces found in the product. The plastic contamination came from ice purchased from a supplier.

    Product
    Fresh Creative Foods PLANT BASED CHICKEN CHIPOTLE PASTA SALAD KIT 2/5.8125 LB UPC: 10013454381820 Item # 404996 Kit Components: 2/4.5 lb. tubs of Chipotle Pasta Salad; 2/15 oz. bags of plant based chipotle seasoned protein strips 2/5 oz. bags of shredded cheddar cheese…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0893-2022·2022-03-23

    Basil Pesto Bowtie Pasta Salad Kits Recalled for Hard Plastic Contamination

    Fresh Creative Foods is recalling Basil Pesto Bowtie Pasta Salad Kits because hard clear plastic pieces were found in the product during manufacturing. The plastic originated from ice purchased from the manufacturer's supplier.

    Product
    Fresh Creative Foods; BASIL PESTO BOWTIE PASTA SALAD DIRECT KIT 2/5.15625 LB UPC: 10013454380922; Item # 404736 Perishable/ Keep Refrigerated Kit components: 2/3 lb. bags of Bowtie Pasta, 2/24 oz. bags of Sweet Basil Dressing, 2/8 oz. bags of diced sundried tomato, 2/2.5 bags…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0791-2022·2022-03-23

    Lumbar Puncture Tray Pediatric Recalled Due to Manometer Failure

    Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.

    Product
    LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0868-2022·2022-03-23

    Rosarita Organic Refried Beans recalled for small rocks contamination

    ConAgra Foods is recalling Rosarita Organic Refried Beans due to possible contamination with small rocks. The recall affects approximately 169,680 cases distributed across seven states.

    Product
    Rosarita Organic Refried Beans Multipack carton containing 8 - 16oz cans
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0781-2022·2022-03-23

    Boston Scientific RX Cholangiogram Kit Recall Due to Sterile Barrier Breach

    Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.

    Product
    RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2022·2022-03-23

    Boston Scientific recalls 68 medical devices with sterility breach

    Boston Scientific is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.

    Product
    JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0762-2022·2022-03-23

    HYDRATOME RX surgical device recalled due to sterile barrier breach

    Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.

    Product
    HYDRATOME RX 44-30MM/450CM Material Number: M00583070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2022·2022-03-23

    FDA Recalls Safe-T PLUS Pediatric Lumbar Puncture Tray Due to Manometer Failure

    Bard Peripheral Vascular Inc is recalling 20,400 Safe-T PLUS pediatric lumbar puncture trays due to manometer leaking and mating failures. The devices were distributed nationwide and internationally to healthcare facilities.

    Product
    Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0886-2022·2022-03-23

    Stutzman Farms Organic All Purpose Flour Recalled for Undeclared Wheat Allergen

    Stutzman Farms is recalling its Organic All Purpose Flour sold in bulk due to undeclared wheat allergen. The flour was distributed across seven states and may affect individuals with wheat allergies.

    Product
    Stutzman Farms Organic All Purpose Flour sold in bulk
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0771-2022·2022-03-23

    Medical Device Recall: Boston Scientific JAGTOME RX Sterile Barrier Breach

    Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.

    Product
    JAGTOME RX 39-30-260-025 Material Number: M00573100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0859-2022·2022-03-23

    Salted Dried Plums Recalled for High Lead Levels

    Vbest Inc is recalling salted dried plums (saladitos) distributed in California and Washington due to high lead levels detected by the California Department of Public Health. Consumers should not consume the affected product.

    Product
    Salted Dried Plums, 500kgcartons, 20kgs plastic bag/carton
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0778-2022·2022-03-23

    Boston Scientific JAGTOME RX Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.

    Product
    JAGTOME RX 49-30-260-035 Material Number: M00573020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0891-2022·2022-03-23

    Broccoli Cheddar Pasta Salad Recalled Due to Hard Plastic Contamination

    Walmart's Freshness Guaranteed Broccoli Cheddar Pasta Salad is recalled due to hard plastic pieces found during manufacturing. The contamination came from ice purchased from a supplier and affects products with use-by dates of March 14–22, 2022.

    Product
    Freshness Guaranteed BROCCOLI CHEDDAR PASTA SALAD WM 6/14 OZ (397 g) UPC: 0 78742 37256 3 Distributed by Walmart Inc., Bentonville, AR 72716
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0776-2022·2022-03-23

    Medical Device Sterile Barrier Breach: JAGTOME RX Recall

    Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.

    Product
    JAGTOME RX 44-30-450-035 Material Number: M00573070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V172000·2022-03-22

    Marion Body Works Recalls 2018 International SR525 Emergency Vehicle

    Marion Body Works is recalling one 2018 International SR525 emergency vehicle because the engine may overcome the parking brake, increasing crash risk.

    Product
    MARION BODY WORKS — MARION BODY WORKS INTERNATIONAL SR525
    Category
    Vehicle
    Distribution
    Distributed nationwide