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.

14126–14150 of 53090

  • HighFDA (Devices)·Z-1174-2023·2023-03-08

    Monosof nylon sutures recalled for sterile barrier breach

    Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.

    Product
    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2023·2023-03-08

    Surgilon Braided Nylon sutures recalled due to sterile barrier defect

    Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.

    Product
    Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2023·2023-03-08

    Ultracell Wick with Collection Bag Recalled for Compromised Packaging Sterility

    Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.

    Product
    Ultracell Wick with 80cc Collection Bag, 20/box
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Drugs)·D-0393-2023·2023-03-08

    Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations

    Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1206-2023·2023-03-08

    X-ray System Overhead Crane May Continue Moving Unexpectedly

    Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.

    Product
    DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2023·2023-03-08

    Glycopyrrolate Injection, USP recalled for manufacturing practice deviations

    Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0355-2023·2023-03-08

    Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.

    Product
    Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V157000·2023-03-08

    Eveland Scamp Travel Trailer Recall for Gas Leak Risk

    Eveland's Inc. is recalling 2022 Scamp travel trailers because damaged burner control valves may cause a gas leak, increasing fire risk.

    Product
    EVELAND — EVELAND SCAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2023·2023-03-08

    Pravastatin Sodium tablets recalled for manufacturing practice violations

    Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0358-2023·2023-03-08

    Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure

    FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V149000·2023-03-07

    Kia K5 side curtain air bags may not deploy in crash

    Kia is recalling 2021-2023 K5 vehicles due to potentially incorrect installation of side curtain air bags that could prevent proper deployment in a crash.

    Product
    KIA — KIA K5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V146000·2023-03-06

    2023 Triumph Bonneville T120 motorcycles recalled for brake disc detachment risk

    Triumph is recalling certain 2023 Bonneville T120 motorcycles because the left-hand side brake disc may detach, reducing brake performance and increasing crash risk. Dealers will install replacement parts free of charge.

    Product
    TRIUMPH — TRIUMPH BONNEVILLE T120
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·006-2023·2023-03-04

    GH Foods Recalls Trader Joe's Lemon Chicken Salad Due to Undeclared Wheat

    GH Foods NW, LLC is recalling approximately 106 pounds of Trader Joe's Lemon Chicken & Arugula Salad because the label fails to declare wheat, a known allergen.

    Product
    F&S Produce West LLC — GH Foods NW, LLC Recalls Ready-to-Eat Salad with Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V142000·2023-03-03

    2023 Toyota Tundra Hybrid Tonneau Cover May Detach While Driving

    Toyota is recalling 2022-2023 Tundra and Tundra Hybrid trucks with Toyota genuine tonneau covers. The cover's attachment joints may loosen and allow the cover to detach while driving, creating a road hazard.

    Product
    TOYOTA — TOYOTA TUNDRA, TUNDRA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V143000·2023-03-03

    2023 Mack Granite Trucks Recalled for Loose Axle Fasteners

    Mack is recalling approximately 17 model-year 2023 Granite trucks because front-drive steer axle fasteners may not have been properly tightened and could come loose, risking loss of steering control and crashes.

    Product
    MACK — MACK GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23730·2023-03-02

    Multi-Purpose Kids Bike Helmets Recalled for Head Injury Risk

    Ouwoer Kids Bike Helmets sold on Amazon from March to November 2022 fail to meet federal safety standards and may not protect children in a crash. About 120 units are affected; no injuries have been reported.

    Product
    Multi-Purpose Kids Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23138·2023-03-02

    Patagonia Infant Capilene Base Layer Sets Recalled for Choking Hazard

    Patagonia is recalling about 8,000 Infant Capilene Midweight Base Layer Sets because snaps on the bodysuit can detach, posing a choking hazard to infants. One incident of a snap detaching and being mouthed by a baby has been reported.

    Product
    Infant Capilene Midweight Base Layer Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V138000·2023-03-02

    Newmar Motorhome Entry Door Latch May Fail, Preventing Emergency Exit

    Newmar is recalling certain 2021-2023 Bay Star, Bay Star Sport, and Canyon Star motorhomes because the entry door latch may fail and prevent entry or exit, increasing the risk of injury in emergencies.

    Product
    NEWMAR — NEWMAR BAY STAR, CANYON STAR, BAY STAR SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23140·2023-03-02

    RELiON InSight Series Lithium Batteries Recalled for Thermal Burn and Fire Risk

    RELiON Battery is recalling certain lots of InSight Series 48V lithium-ion batteries because they can overheat, posing thermal burn and fire hazards. The company has received five reports of overheating with no injuries reported to date.

    Product
    RELiON InSight Series® lithium batteries
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V140000·2023-03-02

    2023 Winnebago Adventurer, Vista, Sunstar motorhomes recalled for missing rear reflectors

    Winnebago is recalling certain 2023 Adventurer, Vista, and Itasca Sunstar motorhomes for missing rear reflectors that fail federal safety standards. Missing reflectors reduce visibility to other drivers, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VISTA, ADVENTURER, SUNSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V139000·2023-03-02

    Off Grid Trailers Recalls 150 Units Due to Gas Leak Risk

    Off Grid Trailers is recalling 150 Expedition, Switchback, and Pando travel trailers because a cooktop component may fracture and cause a gas leak.

    Product
    OFF GRID TRAILERS — OFF GRID TRAILERS EXPEDITION, SWITCHBACK, PANDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23731·2023-03-02

    Classic Whimsy Children's Pajamas Recalled for Flammability Standard Violation

    Smocked Runway is recalling about 7,200 Classic Whimsy children's pajamas that fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. Consumers should stop using the product immediately and contact the manufacturer for return instructions.

    Product
    Classic Whimsy children's pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23139·2023-03-02

    Primark Children's Bamboo Plates Recalled for Lead and Formaldehyde

    Primark is recalling about 1,665 children's bamboo plates sold from October 2021 through August 2022 because they contain elevated levels of lead and formaldehyde, which are toxic if ingested by children.

    Product
    Children's Bamboo Plates
    Category
    Consumer Product
    Distribution
    Distributed nationwide