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.

17726–17750 of 50404

  • HighFDA (Food)·F-0895-2022·2022-03-23

    Fresh Creative Foods Chicken Enchilada Kit Recalled for Plastic Contamination

    Fresh Creative Foods is recalling its Red Sauce Chicken Enchilada Kit due to plastic pieces discovered during manufacturing. The contamination came from ice supplied to the manufacturer.

    Product
    Fresh Creative Foods RED SAUCE CHICKEN ENCHILADA KIT ON PREMISE NO TRAYS 2/6.75 LB UPC: 10013454381929 Item # 404979 Perishable/Keep refrigerated Kit components: 2/32 oz. bags of seasoned chicken w/rib meat, 8/8 pz. bags of Cryo Traditional Red Enchilada Sauce, 8 bags of…
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0857-2022·2022-03-23

    Tolteca Saladitos Salted Dried Plums Recalled Due to Potential High Lead Levels

    Candies Tolteca is recalling Tolteca Saladitos Salted Dried Plums due to potential high lead contamination. Consumers should not consume affected product.

    Product
    Tolteca Saladitos Salted Dried Plums; Net Wt. 1.5 oz. (42.5g) packaged in a clear cellophane bag approximately (4 x 8 ). The name SALADITOS Salted Dried Plums appears on a Blue TOLTECA brand label and identified with UPC Code 704927600694 Packed by Candies Toletca P.O. Box…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0880-2022·2022-03-23

    Stutzman Farms Sprouted Einkorn Crackers recalled for undeclared wheat allergen

    Stutzman Farms is recalling Sprouted Einkorn Crackers sold in 0.30lb and 1lb bags due to undeclared wheat allergen. The affected product was distributed in Indiana, Kentucky, Michigan, Missouri, Ohio, Pennsylvania, and Wisconsin.

    Product
    Stutzman Farms Sprouted Einkorn Crackers sold in .30lb and 1lb bags
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0757-2022·2022-03-23

    Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise

    Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.

    Product
    DREAMTOME 49-30MM/260CM Material Number: M00584010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2022·2022-03-23

    Hydratome RX 44-20MM medical device recalled for sterile barrier breach

    Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.

    Product
    HYDRATOME RX 44-20MM/450CM Material Number: M00583060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2022·2022-03-23

    Boston Scientific DREAMTOME medical devices recalled for sterile barrier breach

    Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.

    Product
    DREAMTOME 49-20MM/260CM Material Number: M00584000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2022·2022-03-23

    FDA Recalls Adult Lumbar Puncture Trays for Manometer and Connector Defects

    Bard Peripheral Vascular is recalling 116,770 adult lumbar puncture trays due to manometer leaks and connector mating defects that could affect procedure performance.

    Product
    LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V177000·2022-03-23

    Bentley seat belt assembly defect may impair child restraint function

    Bentley Motors is recalling certain 2020-2022 Continental GT and Flying Spur vehicles due to incorrectly installed front seat belt assemblies that may lack an automatic locking retractor, potentially failing to secure child restraints properly in a crash.

    Product
    BENTLEY — BENTLEY CONTINENTAL GT, FLYING SPUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0890-2022·2022-03-23

    Thai Noodle Salad Recalled for Plastic Fragments

    Fresh Creative Foods is recalling Thai Noodle Salad due to hard clear plastic pieces found during manufacturing. The contamination originated from ice supplied to the manufacturer.

    Product
    Fresh Creative Foods THAI NOODLE SALAD NO CORN BULK 2/5 LB Kroger UPC: 10013454381974 Item # 404972 Distributed by Fresh Creative Foods, Vista, CA 92081
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0751-2022·2022-03-23

    Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.

    Product
    Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2022·2022-03-23

    Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier

    Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.

    Product
    JAGTOME RX 44-20-450-035 Material Number: M00573050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0888-2022·2022-03-23

    Fresh Creative Foods Lemon Capellini Salad Recalled for Plastic Contamination

    Fresh Creative Foods is recalling Lemon Capellini Salad due to hard clear plastic pieces found in the product. The contamination source was traced to ice purchased from a supplier.

    Product
    Fresh Creative Foods LEMON CAPELLINI SALAD 2/4.5 LB Perishable/Keep refrigerated. UPC: 10013454373672 Item number: 403207 Distributed by: Fresh Creative Foods, Vista, CA 92081
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0756-2022·2022-03-23

    DREAMTOME medical device recall: sterility compromised by barrier breach

    Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.

    Product
    DREAMTOME 49-20MM/450CM Material Number: M00584020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2022·2022-03-23

    Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects

    Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.

    Product
    LUMBAR PUNCTURE DRUG FREE TRAY 22G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2022·2022-03-23

    Diagnostic ultrasound system ACUSON Juniper fails to save study clips

    The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

    Product
    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V174000·2022-03-23

    2022 Alliance RV Valor Travel Trailers Recalled for Electrical Fire Hazard

    Alliance RV is recalling certain 2022 Valor, Paradigm, and Avenue travel trailers due to faulty power inlet bolts that can cause loose wiring and electrical fire risk. Dealers will replace the power inlet free of charge.

    Product
    ALLIANCE RV — ALLIANCE RV PARADIGM, AVENUE, VALOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2022·2022-03-23

    Boston Scientific HYDRATOME RX Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.

    Product
    HYDRATOME RX 44-20MM/260CM Material Number: M00583040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2022·2022-03-23

    FDA Recalls SAFE-T PLUS Lumbar Puncture Trays for Device Malfunction

    Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.

    Product
    SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2022·2022-03-23

    Lumbar Puncture Tray Recalled for Manometer Leaking and Connection Issues

    Bard Peripheral Vascular is recalling 29,870 lumbar puncture trays due to manometer failure that causes leaking and improper connections. The defect could compromise device function during lumbar puncture procedures.

    Product
    LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0874-2022·2022-03-23

    Bob Evan's Mashed Potatoes Recalled for Undeclared Wheat Allergen

    Bob Evan's Sour Cream & Chive Mashed Potatoes recalled due to incorrect packaging that failed to declare wheat allergen. Consumers with wheat allergies should not consume this product.

    Product
    Bob Evan's Sour Cream & Chive Mashed Potatoes 24oz plastic trays with clear film and sleeve over wrap sold as singles to consumers
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0889-2022·2022-03-23

    Basil Pesto Sauce Recalled Due to Plastic Contamination

    RMJV LP's First Street brand basil pesto sauce is recalled because hard plastic pieces were found in the product during manufacturing, traced to supplier ice.

    Product
    BASIL PESTO SAUCE FIRST STREET 6/8 OZ UPC: 0 41512 15550 5 Perishable. Keep refrigerated. Distributed by Amerifoods Trading Co. Los Angeles, CA 90051
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0782-2022·2022-03-23

    LINQ II Insertable Cardiac Monitor Recalled for Moisture Ingress

    Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.

    Product
    LINQ II Insertable Cardiac Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2022·2022-03-23

    Abbott Alinity s System software error affects diagnostic analyzer wash cycle

    Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.

    Product
    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of…
    Category
    Medical Device
    Distribution
    Distributed nationwide