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.

20401–20425 of 50413

  • HighFDA (Devices)·Z-1613-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate glucose readings.

    Product
    Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0546-2021·2021-05-26

    South Georgia Pecan Company Recalls Pecan Halves Due to Peanut Complaints

    South Georgia Pecan Company is recalling 30-pound cases of Fancy Seed Pecan Halves because consumers reported finding peanuts in the product.

    Product
    FANCY SEED PECAN HALVES 750 STERILIZED NET WT 30.00 Ingredients: Pecans Allergens: Pecans SOUTH GEORGIA PECAN Co. P.O.. Box 5366 Valdosta, GA 31603 800-627-6630
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1618-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recall for Hydroxyurea Interaction

    Medtronic is recalling 207 units of Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated glucose readings.

    Product
    Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1636-2021·2021-05-26

    Biopsybell Easynject Device Recalled for Potential Sterility Failure

    Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.

    Product
    EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0551-2021·2021-05-26

    Udi Gluten Free Banana Chocolate Chip Muffins Recalled for Plastic

    Conagra Brands is recalling Udi Gluten Free Banana Chocolate Chip Muffins due to the potential presence of plastic.

    Product
    Udi Gluten Free Banana Chocolate Chip Muffins, 10oz retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81012-4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2021·2021-05-26

    Biopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns

    Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.

    Product
    10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2021·2021-05-26

    WillowWood Alpha Interlock Suspension System Lanyard Body Recalled for Pin Defect

    WillowWood Global LLC is recalling 815 Alpha Interlock Suspension System Lanyard Bodies because a shorter dowel pin was used, which may cause the suspension cord to slip or come loose.

    Product
    Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate elevated glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1608-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate glucose readings when used with hydroxyurea.

    Product
    Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1614-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings

    Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0536-2021·2021-05-26

    Russ Davis Wholesale Recalls Veggie Pizza for Undeclared Soy Lecithin

    Russ Davis Wholesale Inc. is recalling 536 units of Veggie Pizza sold in six states because the product contains undeclared soy lecithin.

    Product
    Veggie Pizza sold under the following brands: Crazy Fresh, quick & easy, and blank label. Item # 81068, Net Wt. 6.2 oz., UPC 7 95631 81068 4. Keep Refrigerated. Manufactured By: RDW St. Paul, MN 55121
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1600-2021·2021-05-26

    Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated readings.

    Product
    Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1609-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

    Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.

    Product
    Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0552-2021·2021-05-26

    Udi Gluten Free Chocolate Zucchini Muffins Recalled for Plastic Contamination

    Conagra Brands is recalling Udi Gluten Free Chocolate Zucchini Muffins due to the potential presence of plastic. Consumers should stop eating the product.

    Product
    Udi Gluten Free Chocolate Zucchini Muffins, 10oz retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81014-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Mold Contamination

    Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0493-2021·2021-05-26

    Desserts On Us Pistachio Baklava Recalled for Undeclared Milk Allergen

    Desserts On Us, Inc. is recalling 120 units of Original Pistachio Traditional Baklava because the packaging failed to declare milk as an ingredient.

    Product
    Desserts On Us Original Pistachio Traditional Baklava: Net Wt. 4 oz., (113g) UPC: 7 59098 51005 2 Desserts On Us, 57 Belle Falor Court, Arcata, CA 95521 Ingredients: Pistachios, sugar, filo dough [wheat flour(enriched with niacin, iron, thiamine mononitrate…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1663-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2021·2021-05-26

    RayStation Software Recall Due to Dose Labeling Error in Merged Beams

    RaySearch Laboratories is recalling RayStation and RayPlan software versions due to a defect that may mislabel approximate radiation doses as clinical doses.

    Product
    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2021·2021-05-26

    Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea

    Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.

    Product
    Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0538-2021·2021-05-26

    PepsiCo Recalls Evolve Vanilla Bean Protein Shakes for Undeclared Soy

    PepsiCo is recalling Evolve Vanilla Bean Plant-Based Protein Shakes because they contain undeclared soy. The recall covers 14,830 cases distributed nationwide.

    Product
    Evolve Vanilla Bean Plant-Based Protein Shake, 11oz "Tetra Pak" carton, sold 4 cartons per retail unit. UPC on retail 4 pack: 876063007870 Packed 3 retail four packs per wholesale case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V389000·2021-05-25

    Tesla Recalls Model 3 and Model Y for Seat Belt Fastener Defect

    Tesla is recalling 2018-2020 Model 3 and 2019-2021 Model Y vehicles because front seat belt fasteners may not be properly attached, increasing injury risk.

    Product
    TESLA — TESLA MODEL Y, MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide