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.

22851–22875 of 50430

  • HighFDA (Devices)·Z-2372-2020·2020-06-24

    Biosense Webster PENTARAY NAV Mapping Catheter Recall for Entrapment Risk

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the cardiac valvular apparatus during use.

    Product
    PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1304-2020·2020-06-24

    AvKARE Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2020·2020-06-24

    Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters

    Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the heart's valves during use.

    Product
    PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V366000·2020-06-23

    Ford Recalls 2020 Expedition and Lincoln Navigator for Headrest Weld Defect

    Ford is recalling 2020 Expedition and Lincoln Navigator vehicles because a driver's side second-row seat headrest bracket may be improperly welded, potentially failing to restrain occupants in a crash.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V361000·2020-06-19

    2021 Forest River FR3 Leveling Jack Wiring Defect Poses Crash Risk

    The 2021 Forest River FR3 recreational vehicle has a wiring harness defect that can cause leveling jacks to deploy while driving, risking loss of vehicle control. Forest River will provide free repairs.

    Product
    FOREST RIVER — FOREST RIVER FR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V363000·2020-06-19

    2020-2021 Motorhomes Recalled for Brake Hose Chafing Risk

    Certain 2020-2021 motorhomes built on Sprinter chassis may develop a brake hose chafed by the fender liner, potentially losing brake fluid. Owners should have dealers inspect and replace brake hoses and modify fender liners at no cost.

    Product
    COACHMEN — COACHMEN, DYNAMAX, FOREST RIVER GALLERIA, ISATA, BATTISTI, SUNSEEKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V362000·2020-06-19

    Grand Design Recalls 2016-2018 Reflection Trailers for Wiring Fire Risk

    Grand Design is recalling 2016-2018 Reflection trailers because a wiring connector may allow water intrusion, potentially causing an electrical short circuit and fire.

    Product
    GRAND DESIGN — GRAND DESIGN REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20752·2020-06-18

    Modus Furniture Recalls Dressers Due to Tip-Over and Entrapment Hazards

    Modus Furniture is recalling Brighton, Travis, and Bevelle dressers because they are unstable without mirrors, posing tip-over and entrapment risks to children.

    Product
    Brighton, Travis and Bevelle dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2020·2020-06-17

    Genicon Natura Cannula Recall Due to Detachable Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-151 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2305-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2020·2020-06-17

    Genicon GENILook Laparoscopic Scope Recall Due to Detaching Optical Tip

    Genicon, Inc. is recalling GENILook Model 200-005-153 laparoscopic scopes because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2271-2020·2020-06-17

    Genicon GENILook Medical Device Recalled Due to Detached Optical Tip Risk

    Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2295-2020·2020-06-17

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.

    Product
    FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2020·2020-06-17

    Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk

    Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2020·2020-06-17

    Genicon GENILook Cannula Recalled for Potential Tip Detachment

    Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.

    Product
    Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2347-2020·2020-06-17

    RayStation 8B Service Pack 1 Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.

    Product
    RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0983-2020·2020-06-17

    Wild Harvest Organic Fresh Basil Recalled for Cyclospora Contamination Risk

    UNFI General Corporate is recalling Wild Harvest Organic Fresh Basil due to potential contamination with Cyclospora cayetanensis. The product was distributed in Minnesota, South Dakota, and Wisconsin.

    Product
    Wild Harvest Organic Fresh Basil packaged in the following sized plastic containers: Net Wt 2 oz (57g), UPC 11535-50762, Net Wt 0.25 oz. (7g), UPC 11535-50450, Net Wt 0.75 oz. (21g), UPC 11535-50322, Net Wt. 4 oz. (113g), UPC 11535-50323. Distributed by…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2289-2020·2020-06-17

    Elekta Unity Radiation Therapy System Recalled for Legionella Risk

    Elekta, Inc. is recalling 32 Unity image-guided radiation therapy systems due to a potential risk of Legionella presence in the machine room heat exchanger condensation collection tray.

    Product
    Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2335-2020·2020-06-17

    Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2331-2020·2020-06-17

    Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error

    Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2333-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558…
    Category
    Medical Device
    Distribution
    0 states