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.

13201–13225 of 22165

  • HighFDA (Food)·F-0577-2024·2023-12-20

    Greek Feta Dressing and Related Products Recalled for Temperature Abuse

    Ben E Keith Foods is recalling Greek Feta dressing and other refrigerated and frozen foods shipped in a temperature-abused trailer, affecting 1,721 cases total. No illnesses have been reported.

    Product
    DRESSING GREEK FETA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0575-2024·2023-12-20

    Frozen Vegetable Products Recalled Due to Temperature Abuse During Transport

    Ben E Keith Foods is recalling approximately 1,721 cases of multiple frozen vegetable and side-dish products due to temperature abuse during shipment. Consumers should discard affected products.

    Product
    TATER KEG BACON CHEDDAR CHIVE; OKRA CUT HEAVILY BREADED IQF; POTATO TATER TOTS; FRENCH FRIES SC 3/8 IN; JALAPENO STUFFED W/CHDR CHS; CORN CUT; BEAN GREEN REGULAR CUT; BEAN GREEN SPICY BREADED; ONION RING BEER BATTERED 5/8IN; PICKLE FRIES BREADED MUSHROOM BATTERED
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0550-2024·2023-12-20

    Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures

    Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.

    Product
    Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2024·2023-12-20

    Sterile PVP Solution Kit Recalled for Non-Sterile Contents

    Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.

    Product
    STERILE PVP SLN KIT, REF DYNDM1097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2024·2023-12-20

    Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents

    Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.

    Product
    STERILE PVP SOLUTION, REF DYNDA1907
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2024·2023-12-20

    Olympus tracheal intubation fiberscope recalled due to suction flow specification issue

    Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.

    Product
    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0505-2024·2023-12-20

    TYSON 2.0 Kava & Kratom Supplement Recalled for Unapproved Additive and pH Control Failure

    LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.

    Product
    TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, FRUIT PUNCH, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583622, POWERED BY LGNDS, 12 bottles of 2oz each per
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0567-2024·2023-12-20

    Sheetz snack mix recalled for undeclared soy allergen

    Sheetz M.T.go! Double Dipped Chocolatey Peanut Butter Peanuts Snax Mix is being recalled because it contains undeclared soy. The product was distributed in North Carolina, Virginia, and West Virginia.

    Product
    Top Label Reads: SHEETZ M.T.go! Made"To"Go DOUBLE DIPPED CHOCOLATEY PEANUT BUTTER PEANUTS SNAX MIX NET WT 6.55 OZ (186 G) Back Panel Reads: SWEET & SPICY SNAX MIX DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 7 59465 00629 3
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0519-2024·2023-12-20

    Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect

    Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.

    Product
    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2024·2023-12-20

    Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk

    Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.

    Product
    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2024·2023-12-20

    Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling

    Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.

    Product
    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
    Category
    Medical Device
    Distribution
    5 states
  • HighCPSC·24734·2023-12-14

    Collegiate English Horse-Riding Saddles Recalled for Fall Injury Risk

    WeatherBeeta USA is recalling about 2,300 Collegiate English horse-riding saddles because the rivet or stirrup bar can break, causing the rider to fall. One fall injury has been reported.

    Product
    Collegiate English Horse-Riding Saddles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24058·2023-12-14

    Savvy Rest Quilted Cotton Mattress Pads Recalled for Fire Hazard

    Savvy Rest is recalling about 84 quilted cotton mattress pads because they fail to meet the federal flammability standard for mattress pads and pose a fire hazard. No injuries have been reported.

    Product
    Savvy Rest Quilted Cotton Mattress Pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24051·2023-12-14

    Empower Brands Recalls PowerXL Dual-Basket Air Fryers Due to Burn Hazard

    Empower Brands is recalling about 319,000 PowerXL DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers because the plastic U-Channel connector can break during use, posing a burn hazard. The firm has received 41 reports of breakage, including three burn injuries.

    Product
    PowerXL™ DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24736·2023-12-14

    Kubota RTV-XG850 Utility Vehicles Recalled for Steering Hazards

    Kubota is recalling about 3,170 RTV-XG850 Sidekick utility vehicles sold between March 2023 and September 2023 due to improper steering shaft assembly that could cause loss of control and crash hazards.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24060·2023-12-14

    Room & Board Griffin Duo Bunk Beds Recall Due to Collapse Risk

    Room & Board is recalling about 500 Griffin Duo Bunk Beds sold from May 2013 through May 2017 because some units lack properly installed set screws in the side rail brackets, creating a risk of collapse and fall injuries. Two collapse incidents have been reported with no injuries.

    Product
    Room & Board Griffin Duo Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24055·2023-12-14

    Polaris Ranger XP Kinetic Off-Road Vehicles Recalled Due to Crash Hazard

    Polaris is recalling Model Year 2023-2024 Ranger XP Kinetic recreational off-road vehicles because pressing the brake and throttle pedals together can deactivate the throttle, creating a crash hazard when the brake is released.

    Product
    Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24735·2023-12-14

    Can-Am Side-by-Side Vehicles Recalled for Clutch Failure Risk

    BRP is recalling about 14,555 Model Year 2022 and 2023 Can-Am Commander, Defender, and Maverick Trail side-by-side vehicles because the operator's guide contains incorrect maintenance intervals for the clutch, which can lead to clutch failure and fragment ejection, posing a risk of serious injury.

    Product
    Can-Am® Commander series, Defender series, Maverick Trail series equipped with an HD7 or 700 engines side-by-side vehicles (Model Year 2022 and 2023)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24050·2023-12-14

    Steamfast Travel Steam Irons Recalled for Fire, Burn, and Shock Hazards

    Vornado Air LLC is recalling approximately 1.75 million Steamfast Home & Away Travel Steam Irons because the power cord can become damaged near the bushing, posing fire, burn, and electrical shock hazards.

    Product
    Steamfast Home & Away Travel Steam Irons
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2024·2023-12-13

    Monarch Platform Bronchoscope Software Issue Causes Flipped Display

    Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.

    Product
    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0493-2024·2023-12-13

    Integra Cranial Access Kit packaging defect compromises device sterility

    Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.

    Product
    Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2024·2023-12-13

    Integra Cranial Access Kit recalled over outer packaging defect

    Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators for Design Nonconformance

    Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0430-2024·2023-12-13

    ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing

    Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2024·2023-12-13

    Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

    Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states